Inflator for dilation of anatomical passageway

ABSTRACT

A dilation catheter system is provided to dilate the ostium of a paranasal sinus or some other anatomical passageway (e.g., within the ear, nose, or throat, etc.). The system may include a dilation catheter, a dilator, a guide catheter, and an inflator. The dilation catheter may be positioned between the dilator and the inflator. The guide catheter is configured to guide the dilator into the affected passageway. The inflator may then be actuated to transfer fluid from the inflator, through the dilation catheter, and into the dilator. The transfer of fluid may inflate the dilator to an expanded state to open or dilate the affected passageway. The inflator may include a body, a plunger assembly, and locking features that selectively secure the position of the plunger assembly relative to the body by moving along a path that is transverse to a longitudinal axis defined by the plunger assembly.

PRIORITY

This application is a continuation-in-part of U.S. patent applicationSer. No. 13/837,577, entitled “Inflator for Dilation of AnatomicalPassageway,” filed Mar. 15, 3013, the disclosure of which isincorporated by reference herein.

U.S. patent application Ser. No. 13/837,577 claims priority to U.S.Provisional Pat. App. No. 61/725,523, entitled “Inflator for Dilation ofAnatomical Passageway,” filed Nov. 13, 2012, the disclosure of which isincorporated by reference herein.

U.S. patent application Ser. No. 13/837,577 also claims priority to U.S.Provisional Pat. App. No. 61/698,788, entitled “inflator for Dilation ofAnatomical Passageway,” filed Sep. 10, 2012, the disclosure of which isincorporated by reference herein.

BACKGROUND

In some instances, it may be desirable to dilate an anatomicalpassageway in a patient. This may include dilation of ostia of paranasalsinuses (e.g., to treat sinusitis), dilation of the larynx, dilation ofthe Eustachian tube, dilation of other passageways within the ear, nose,or throat, etc. One method of dilating anatomical passageways includesusing a guide wire and catheter to position an inflatable balloon withinthe anatomical passageway, then inflating the balloon with a fluid(e.g., saline) to dilate the anatomical passageway. For instance, theexpandable balloon may be positioned within an ostium at a paranasalsinus and then be inflated, to thereby dilate the ostium by remodelingthe bone adjacent to the ostium, without requiring incision of themucosa or removal of any bone. The dilated ostium may then allow forimproved drainage from and ventilation of the affected paranasal sinus.A system that may be used to perform such procedures may be provided inaccordance with the teachings of U.S. Pub. No. 2011/0004057, entitled“Systems and Methods for Transnasal Dilation of Passageways in the Ear,Nose or Throat,” published Jan. 6, 2011, the disclosure of which isincorporated by reference herein. An example of such a system is theRelieva® Spin Balloon Sinuplasty™ System by Acclarent, Inc. of MenloPark, Calif.

A variable direction view endoscope may be used with such a system toprovide visualization within the anatomical passageway (e.g., the ear,nose, throat, paranasal sinuses, etc.) to position the balloon atdesired locations. A variable direction view endoscope may enableviewing along a variety of transverse viewing angles without having toflex the shaft of the endoscope within the anatomical passageway. Suchan endoscope that may be provided in accordance with the teachings ofU.S. Pub. No. 2010/0030031, entitled “Swing Prism Endoscope,” publishedFeb. 4, 2010, the disclosure of which is incorporated by referenceherein. An example of such an endoscope is the Acclarent Cyclops™Multi-Angle Endoscope by Acclarent, Inc. of Menlo Park, Calif.

While a variable direction view endoscope may be used to providevisualization within the anatomical passageway, it may also be desirableto provide additional visual confirmation of the proper positioning ofthe balloon before inflating the balloon. This may be done using anilluminating guidewire. Such a guidewire may be positioned within thetarget area and then illuminated, with light projecting from the distalend of the guidewire. This light may illuminate the adjacent tissue(e.g., hypodermis, subdermis, etc.) and thus be visible to the naked eyefrom outside the patient through transcutaneous illumination. Forinstance, when the distal end is positioned in the maxillary sinus, thelight may be visible through the patient's cheek. Using such externalvisualization to confirm the position of the guidewire, the balloon maythen be advanced distally along the guidewire into position at thedilation site. Such an illuminating guidewire may be provided inaccordance with the teachings of U.S. Pub. No. 2012/0078118, entitled“Sinus illumination Lightwire Device,” published Mar. 29, 2012, thedisclosure of which is incorporated by reference herein. An example ofsuch an illuminating guidewire is the Relieva Luma Sentry™ SinusIllumination System by Acclarent, Inc. of Menlo Park, Calif.

It may be desirable to provide easily controlled inflation/deflation ofa balloon in dilation procedures, including procedures that will heperformed only by a single operator. While several systems and methodshave been made and used to inflate an inflatable member such as adilation balloon, it is believed that no one prior to the inventors hasmade or used the invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements and in which:

FIG. 1 depicts a side elevational view of an exemplary dilation cathetersystem;

FIG. 2 depicts a side elevational view of an exemplary illuminatingguidewire suitable for use with the dilation catheter system of FIG. 1;

FIG. 3 depicts a side cross-sectional view of the illuminating guidewireof 2;

FIG. 4 depicts a perspective view of an exemplary endoscope suitable foruse with the dilation catheter system of FIG. 1;

FIG. 5 depicts a side elevational view of the distal end of theendoscope of FIG. 5, showing an exemplary range of viewing angles;

FIG. 6 depicts a perspective view of an exemplary inflator suited foruse with the dilator catheter system of FIG. 1;

FIG. 7 depicts a perspective view of another exemplary inflator suitedfor use with the dilator catheter system of FIG. 1;

FIG. 8 depicts a side view of another exemplary inflator, with a portionremoved, suited for use with the dilator catheter system of FIG. 1;

FIG. 9 depicts a perspective view of another exemplary inflator suitedfor use with the dilator catheter system of FIG. 1;

FIG. 10 depicts a side view of the crank shaft assembly from theinflator of FIG. 9;

FIG. 11 depicts a perspective view of an exemplary pressure gauge;

FIG. 12 depicts a perspective view of another exemplary pressure gauge;

FIG. 13 depicts a perspective view of another exemplary inflator suitedfor use with the dilator catheter system of FIG. 1;

FIG. 14 depicts a perspective view of another exemplary inflator suitedfor use with the dilator catheter system of FIG. 1;

FIG. 15 depicts a perspective view of another exemplary inflator suitedfor use with the dilator catheter system of FIG. 1;

FIG. 16 depicts a perspective view of another exemplary inflator suitedfor use with the dilator catheter system of FIG. 1;

FIG. 17 depicts an exploded view of the inflator of FIG. 16;

FIG. 18 depicts a side elevational view of a housing half of theinflator of FIG. 16;

FIG. 19 depicts an exploded view of a plunger actuation assembly of theinflator of FIG. 16;

FIG. 20A depicts a cross-sectional side view of the inflator of FIG. 16,with the plunger actuation assembly in a distal and locked position;

FIG. 20B depicts a cross-sectional side view of the inflator of FIG. 16,with the plunger actuation assembly in a distal and unlocked position;

FIG. 20C depicts a cross-sectional side view of the inflator of FIG. 16,with the plunger actuation assembly in a proximal and locked position;

FIG. 21 depicts a perspective view of another exemplary inflator suitedfor use with the dilator catheter system of FIG. 1;

FIG. 22 depicts an exploded view of the inflator of FIG. 21;

FIG. 23 depicts a perspective view of a ratchet block of the inflator ofFIG. 21;

FIG. 24A depicts a cross-sectional side view of the inflator of FIG. 21,with the plunger in a proximal position;

FIG. 24B depicts a cross-sectional side view of the inflator of FIG. 21,with the plunger in a distal position;

FIG. 24C depicts a cross-sectional side view of the inflator of FIG. 21,with the plunger in a distal position, and with a button actuated torelease the ratchet block from the plunger driver;

FIG. 24D depicts a cross-sectional side view of the inflator of FIG. 21,with the plunger in a distal position, with the button released, andwith a latch holding the ratchet block in a position where the ratchetblock remains disengaged from the plunger driver;

FIG. 24E depicts a cross-sectional side view of the inflator of FIG. 21,with the plunger in a proximal position, and with a latch disengagementfeature of the plunger driver disengaging the latch from the ratchetblock;

FIG. 25 depicts a perspective view of another exemplary inflator suitedfor use with the dilator catheter system of FIG. 1;

FIG. 26 depicts an exploded view of the inflator of FIG. 25;

FIG. 27 depicts a cross-sectional side view of the housing of theinflator of FIG. 25;

FIG. 28 depicts a top plan view of the plunger actuation assembly of theinflator of FIG. 25;

FIG. 29 depicts an exploded view of the plunger actuation assembly ofFIG. 28;

FIG. 30A depicts a cross-sectional top view of the inflator of FIG. 25,with the plunger in a distal position and with the plunger actuationassembly in a locked configuration;

FIG. 30B depicts a cross-sectional top view of the inflator of FIG. 25,with the plunger in a distal position and with the plunger actuationassembly in an unlocked configuration;

FIG. 30C depicts a cross-sectional top view of the inflator of FIG. 25,with the plunger in a proximal position and with the plunger actuationassembly in a locked configuration;

FIG. 31 depicts a perspective view of another exemplary inflator suitedfor use with the dilator catheter system of FIG. 1;

FIG. 32 depicts an exploded view of the inflator of FIG. 31;

FIG. 33 depicts a side elevational view of a housing half of theinflator of FIG. 31;

FIG. 34 depicts an exploded view of a plunger actuation assembly of theinflator of FIG. 31;

FIG. 35 depicts a perspective view of an actuator half of the plungeractuation assembly of FIG. 34;

FIG. 36 depicts an enlarged perspective view of components of theplunger actuation assembly of FIG. 34 engaging the housing half of FIG.33;

FIG. 37A depicts a cross-sectional side view of the inflator of FIG. 31,with the plunger actuation assembly in a distal and locked position;

FIG. 37B depicts a cross-sectional side view of the inflator of FIG. 31,with the plunger actuation assembly in a distal and unlocked position;

FIG. 37C depicts a cross-sectional side view of the inflator of FIG. 31,with the plunger actuation assembly in a proximal and unlocked position;

FIG. 38 depicts a perspective view of another exemplary inflator suitedfor use with the dilator catheter system of FIG. 1;

FIG. 39 depicts another perspective view of the inflator of FIG. 38;

FIG. 40 depicts a side elevational view of the inflator of FIG. 38;

FIG. 41 depicts a top plan view of the inflator of FIG. 38;

FIG. 42 depicts a bottom plan view of the inflator of FIG. 38;

FIG. 43 depicts a front elevational view of the inflator of FIG. 38; and

FIG. 44 depicts a partial perspective view of a distal portion of theinflator of FIG. 38.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. For example, while various. Accordingly,the drawings and descriptions should be regarded as illustrative innature and not restrictive.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping a handpiece assembly.Thus, an end effector is distal with respect to the more proximalhandpiece assembly. It will be further appreciated that, for convenienceand clarity, spatial terms such as “top” and “bottom” also are usedherein with respect to the clinician gripping the handpiece assembly.However, surgical instruments are used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

It is further understood that any one or more of the teachings,expressions, versions, examples, etc. described herein may be combinedwith any one or more of the other teachings, expressions, versions,examples, etc. that are described herein. The following-describedteachings, expressions, versions, examples, etc. should therefore not beviewed in isolation relative to each other. Various suitable ways inwhich the teachings herein may be combined will be readily apparent tothose of ordinary skill in the art in view of the teachings herein. Suchmodifications and variations are intended to be included within thescope of the claims.

I. Overview of Exemplary Dilation Catheter System

FIG. 1 shows an exemplary dilation catheter system (10) that may be usedto dilate the ostium of a paranasal sinus; or to dilate some otheranatomical passageway (e.g., within the ear, nose, or throat, etc.).Dilation catheter system (10) of this example comprises a dilationcatheter (20), a guide catheter (30), an inflator (40), and a guidewire(50). By way of example only, dilation catheter system (10) may beconfigured in accordance with at least some of the teachings of U.S.Patent Pub. No. 2011/0004057, the disclosure of which is incorporated byreference herein. In some versions, at least part of dilation cathetersystem (10) is configured similar to the Relieva® Spin BalloonSinuplasty™ System by Acclarent, Inc. of Menlo Park, Calif.

The distal end of dilation catheter (20) includes an inflatable dilator(22). The proximal end of dilation catheter (20) includes a grip (24),which has a lateral port (26) and an open proximal end (28). Dilationcatheter (20) includes a first lumen (not shown) that provides fluidcommunication between lateral port (26) and the interior of dilator(22). Dilator catheter (20) also includes a second lumen (not shown)that extends from open proximal end (28) to an open distal end that isdistal to dilator (22). This second lumen is configured to slidablyreceive guidewire (50). The first and second lumens of dilator catheter(20) are fluidly isolated from each other. Thus, dilator (22) may beselectively inflated and deflated by communicating fluid along the firstlumen via lateral port (26) while guidewire (50) is positioned withinthe second lumen. In some versions, dilator catheter (20) is configuredsimilar to the Relieva Ultirra™ Sinus Balloon Catheter by Acclarent,Inc. of Menlo Park, Calif. In some other versions, dilator catheter (20)is configured similar to the Relieva Solo Prom™ Sinus Balloon Catheterby Acclarent, Inc. of Menlo Park, Calif. Other suitable forms thatdilator catheter (20) may take will be apparent to those of ordinaryskill in the art in view of the teachings herein.

Guide catheter (30) of the present example includes a bent distal end(32) and a grip (34) at its proximal end. Grip (34) has an open proximalend (36). Guide catheter (30) defines a lumen that is configured toslidably receive catheter (20), such that guide catheter (30) may guidedilator (22) out through bent distal end (32). in some versions, guidecatheter (30) is configured similar to the Relieva Flex™ Sinus GuideCatheter by Acclarent, Inc. of Menlo Park, Calif. Other suitable formsthat guide catheter (30) may take will be apparent to those of ordinaryskill in the art in view of the teachings herein.

Inflator (40) of the present example comprises a barrel (42) that isconfigured to hold fluid and a plunger (44) that is configured toreciprocate relative to barrel (42) to selectively discharge fluid from(or draw fluid into) barrel (42). Barrel (42) is fluidly coupled withlateral port (26) via a flexible tube (46). Thus, inflator (40) isoperable to add fluid to dilator (22) or withdraw fluid from dilator(22) by translating plunger (44) relative to barrel (42). In the presentexample, the fluid communicated by inflator (40) comprises saline,though it should be understood that any other suitable fluid may beused. There are various ways in which inflator (40) may be filled withfluid (e.g., saline, etc.). By way of example only, before flexible tube(46) is coupled with lateral port (26), the distal end of flexible tube(46) may be placed in a reservoir containing the fluid. Plunger (44) maythen be retracted from a distal position to a proximal position to drawthe fluid into barrel (42). Inflator (40) may then be held in an uprightposition, with the distal end of barrel (42) pointing upwardly, andplunger (44) may then be advanced to an intermediate or slightly distalposition to purge any air from barrel (42). The distal end of flexibletube (46) may then be coupled with lateral port (26).

As best seen in FIGS. 2-3, guidewire (50) of the present examplecomprises a coil (52) positioned about a core wire (54). An illuminationfiber (56) extends along the interior of core wire (54) and terminatesin an atraumatic lens (58). A connector (55) at the proximal end ofguidewire (50) enables optical coupling between illumination fiber (56)and a light source (not shown). Illumination fiber (56) may comprise oneor more optical fibers. Lens (58) is configured to project light whenillumination fiber (56) is illuminated by the light source, such thatillumination fiber (56) transmits light from the light source to thelens (58). In some versions, the distal end of guidewire (50) is moreflexible than the proximal end of guidewire (50). Guidewire (50) has alength enabling the distal end of guidewire (50) to be positioned distalto dilator (22) while the proximal end of guidewire (50) is positionedproximal to grip (24). Guidewire (50) may include indicia along at leastpart of its length (e.g., the proximal portion) to provide the operatorwith visual feedback indicating the depth of insertion of guidewire (50)relative to dilation catheter (20). By way of example only, guidewire(50) may be configured in accordance with at least some of the teachingsof U.S. Pub. No. 2012/0078118, the disclosure of which is incorporatedby reference herein. In some versions, guidewire (50) is configuredsimilar to the Relieva Luma Sentry™ Sinus Illumination System byAcclarent, Inc. of Menlo Park, Calif. Other suitable forms thatguidewire (50) may take will be apparent to those of ordinary skill inthe art in view of the teachings herein,

In an exemplary dilation procedure, guide catheter (30) may first bepositioned near the targeted anatomical passageway, such as a sinusostium (O). Dilator (22) and the distal end of guidewire (50) may bepositioned within or proximal to bent distal end (32) of guide catheter(30) at this stage. Guide catheter (30) is initially inserted into thenose of the patient and is advanced to a position that is within or nearthe ostium (O) to be dilated. This positioning of guide catheter (30)may be performed under visualization provided by an endoscope such asendoscope (60) described below. After guide catheter (30) has beenpositioned, the operator may advance guidewire (50) distally throughguide catheter (30) such that a distal portion of the guidewire (50)passes through the sinus ostium (O) and into the sinus cavity. Theoperator may illuminate illumination fiber (56) and lens (58), which mayprovide transcutaneous illumination through the patient's face to enablethe operator to visually confirm positioning of the distal end ofguidewire (50) with relative ease.

With guide catheter (30) and guidewire (50) suitably positioned,dilation catheter (20) is advanced along guidewire (50) and through bentdistal end (32) of guide catheter (30), with dilator (22) in anon-dilated state until dilator (22) is positioned within the sinusostium (0) (or some other targeted anatomical passageway). After dilator(22) has been positioned within the ostium (O), dilator (22) may beinflated, thereby dilating the ostium. To inflate dilator (22), plunger(44) may be actuated to push saline from barrel (42) of inflator (40)through dilation catheter (20) into dilator (22). The transfer of fluidexpands dilator (22) to an expanded state to open or dilate the ostium(O), such as by remodeling the bone, etc., forming ostium (O). By way ofexample only, dilator (22) may be inflated to a volume sized to achieveabout 10 to about 12 atmospheres. Dilator (22) may be held at thisvolume for a few seconds to sufficiently open the ostium (O) (or othertargeted anatomical passageway). Dilator (22) may then be returned to anon-expanded state by reversing plunger (44) of inflator (40) to bringthe saline back to inflator (40). Dilator (22) may be repeatedlyinflated and deflated in different ostia and/or other targetedanatomical passageways. Thereafter, dilation catheter (20), guidewire(50), and guide catheter (30) may be removed from the patient.

In some instances, it may be desirable to irrigate the sinus andparanasal cavity after dilation catheter (20) has been used to dilate anostium (O). Such irrigation may be performed to flush out blood, etc.that may be present after the dilation procedure. By way of exampleonly, such irrigation may be carried out in accordance with at leastsome of the teachings of U.S. Pub. No. 2008/0138128, entitled “Methods,Devices and Systems for Treatment and/or Diagnosis of Disorders of theEar, Nose and Throat,” published Jul. 31, 2008, the disclosure of whichis incorporated by reference herein. An example of an irrigationcatheter that may be fed through guide catheter (30) to reach theirrigation site after removal of dilation catheter (20) is the RelievaVortex® Sinus Irrigation Catheter by Acclarent, Inc. of Menlo Park,Calif. Another example of an irrigation catheter that may be fed throughguide catheter (30) to reach the irrigation site after removal ofdilation catheter (20) is the Relieva Ultirra® Sinus Irrigation Catheterby Acclarent, Inc. of Menlo Park, Calif. Of course, irrigation may beprovided in the absence of a dilation procedure; and a dilationprocedure may be completed without also including irrigation.

II. Overview of Exemplary Endoscope

As noted above, an endoscope (60) may be used to provide visualizationwithin an anatomical passageway (e.g., within the nasal cavity, etc.)during a process of using dilation catheter system (10). As shown inFIGS. 4-5, endoscope of the present example comprises a body (62) and arigid shaft (64) extending distally from body (62). The distal end ofshaft (64) includes a curved transparent window (66). A plurality of rodlenses and light transmitting fibers may extend along the length ofshaft (64). A lens is positioned at the distal end of the rod lenses anda swing prism is positioned between the lens and window (66). The swingprism is pivotable about an axis that is transverse to the longitudinalaxis of shaft (64). The swing prism defines a line of sight that pivotswith the swing prism. The line of sight defines a viewing angle relativeto the longitudinal axis of shaft (64). This line of sight may pivotfrom approximately 0 degrees to approximately 120 degrees, fromapproximately 10 degrees to approximately 90 degrees, or within anyother suitable range. The swing prism and window (66) also provide afield of view spanning approximately 60 degrees (with the line of sightcentered in the field of view). Thus, the field of view enables aviewing range spanning approximately 180 degrees, approximately 140degrees, or any other range, based on the pivot range of the swingprism. Of course, all of these values are mere examples.

Body (62) of the present example includes a light post (70), an eyepiece(72), a rotation dial (74), and a pivot dial (76). Light post (70) is incommunication with the light transmitting fibers in shaft (64) and isconfigured to couple with a source of light, to thereby illuminate thesite in the patient distal to window (66). Eyepiece (72) is configuredto provide visualization of the view captured through window (66) viathe optics of endoscope (60). It should be understood that avisualization system (e.g., camera and display screen, etc.) may becoupled with eyepiece (72) to provide visualization of the view capturedthrough window (66) via the optics of endoscope (60). Rotation dial (74)is configured to rotate shaft (64) relative to body (62) about thelongitudinal axis of shaft (64). It should be understood that suchrotation may be carried out even while the swing prism is pivoted suchthat the line of sight is non-parallel with the longitudinal axis ofshaft (64). Pivot dial (76) is coupled with the swing prism and isthereby operable to pivot the swing prism about the transverse pivotaxis. Indicia (78) on body (62) provide visual feedback indicating theviewing angle. Various suitable components and arrangements that may beused to couple rotation dial (74) with the swing prism will be apparentto those of ordinary skill in the art in view of the teachings herein.By way of example only, endoscope (60) may be configured in accordancewith at least some of the teachings of U.S. Pub. No. 2010/0030031, thedisclosure of which is incorporated by reference herein. In someversions, endoscope (60) is configured similar to the Acclarent Cyclops™Multi-Angle Endoscope by Acclarent, Inc. of Menlo Park, Calif. Othersuitable forms that endoscope (60) may take will be apparent to those ofordinary skill in the art in view of the teachings herein

III. Exemplary Alternative Inflators

Inflator (40) shown in FIG. 1 and described above is just one example ofan inflator that may be incorporated into dilator catheter system (10).Additional merely illustrative examples of alternative forms thatinflator (40) may take will be described in greater detail below. Itshould be understood that these exemplary alternative inflators may bereadily coupled with flexible tube (46) in place of inflator (40)described above, for use in dilator catheter system (10). In someversions, the exemplary alternative inflators described below may bedirectly coupled with lateral port (26), such that flexible tube (46) issimply omitted. Other suitable configurations and arrangements will beapparent to those of ordinary skill in the art in view of the teachingsherein.

A. Exemplary Alternative Inflator with Knob and Pushbutton ThreadRelease

FIG. 6 shows an exemplary inflator (150) that comprises a body (160), anactuator knob (164), and a pressure gauge (162). Body (160) of thepresent example is formed as a substantially hollow cylinder, similar tosyringe barrel (42) described above, although other suitableconfigurations may be used. Body (160) comprises a reservoir (168), adistal port (170), and a proximal cap (172). A rod (165) extends intobody (160). Plunger (167) is coupled to a distal end of rod (165) andextends outwardly to the inner diameter of body (160) to form asubstantially fluid tight seal with body (160). The volume betweenplunger (167) and the distal end of body (160) forms reservoir (168).Reservoir (168) may be configured to hold about 3 to about 5 cc of fluid(e.g., saline). Rod (165) and plunger (167) may translate proximally anddistally to adjust the size of reservoir (168). When rod (165) andplunger (167) translate proximally, the volume of reservoir (168)increases. When rod (165) and plunger (167) translate distally, thevolume of reservoir (168) decreases. Port (170) at the distal end ofbody (160) is in fluid communication with reservoir (168) such thatfluid may flow into and out of reservoir (168) via port (170). Port(170) may be coupled with flexible tube (46) of dilator catheter system(10).

Actuator knob (164) is coupled to body (160) via a threaded shaft (166),which is in selective threaded engagement with proximal cap (172) ofbody (160). Threaded shaft (166) is configured to rotate unitarily withactuator knob (164). Thus, rotation of actuator knob (164) relative tobody (160) will cause threaded shaft (166) to translate relative to body(160) when the threading of threaded shaft (166) is engaged withproximal cap (172). Threaded shaft (166) is further coupled with rod(165) such that when actuator knob (164) is rotated relative to body(160), rod (165) and plunger (167) translate proximally or distallyrelative to body (165) based on the direction in which actuator knob(164) and threaded shaft (166) are rotated. In some versions, threadedshaft (166) and rod (165) are the same structure, such that threadedshaft (166) extends all the way to plunger (167). In some such versions,threaded shaft (166) rotates freely relative to plunger (167).

In the present example, push button (152) is operable to disengage thethreading of threaded shaft (166) relative to proximal cap (172), tothereby permit threaded shaft (166) to translate freely relative to body(160) when push button (152) is in a depressed position. Varioussuitable features that may be used to provide such operability will beapparent to those of ordinary skill in the art in view of the teachingsherein. By way of example only, the threading of threaded shaft (166)may be selectively retractable inwardly relative to the longitudinalaxis of threaded shaft (166). A translating cam component (not shown)that is coupled with push button (152) may be operable to extend and/orretract the threading of threaded shaft (166) based on the position ofpush button (152). For instance, when push button (152) is not beingdepressed, the cam component may be biased to a position where it urgesthe threading outwardly and holds the threading in the outward position,into engagement with threaded cap (172). The threading may itself beresiliently biased to retract inwardly, such that when push button (152)is depressed, the cam component disengages the threading and thethreading retracts inwardly to disengage body (160). It should also beunderstood that push button (152) may be resiliently biased toward thenon-depressed position. Still other suitable components andconfigurations that may be used to provide the above-described selectiveengagement between threaded shaft (166) and proximal cap (172) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

Gauge (162) of the present example is positioned distal of reservoir(168) to measure the pressure within dilator catheter system (10). Gauge(162) may include a pivoting pin that indicates fluid pressure based onthe angular position of the pin. Alternatively, gauge (162) may provideany other suitable type of indication of fluid pressure, including butnot limited to the other types of fluid pressure indication. describedbelow. In the present example, gauge (162) is operable to indicatepressure levels up to at least about 12 atmospheres. For instance, someuses of dilator catheter system (10) may include inflation of dilator(22) to a range between about 10 atmospheres and about 12 atmospheres inorder to sufficiently dilate a targeted anatomical passageway. Gauge(162) may thus provide the operator with real time feedback indicatingthe fluid pressure within dilator (22) to enable the operator todetermine whether the desired pressure level has been achieved.

In an exemplary use of inflator (150), a operator may start with plunger(167) advanced to a distal position in body (160). The operator may thenposition port (170) in a bowl or other container of saline to draw fluidfrom. In instances where port (170) is coupled with one end of flexibletube (46), the operator may position the other end of flexible tube (46)in the saline. In either case, the operator may then retract plunger(167) relative to body (160) to draw the saline (or other fluid) intoreservoir (168). In some instances, the operator depresses button (152)to disengage threading of threaded shaft (166) from proximal cap (172),thereby permitting the operator to freely pull plunger (167) proximallywithout having to rotate actuator knob (164). The operator maynevertheless grasp actuator knob (164) in order to translate plunger(167) proximally. The operator may observe the position of plunger (167)relative to indicia on body (160) and may initially draw in more fluidthan the operator expects to need in order to sufficiently inflatedilator (22). The operator may then remove port (170) or flexible tube(46) from the saline container and advance plunger (167) distally inorder to purge air from reservoir (168). For instance, the operator mayorient inflator (150) such that port (170) is positioned upwardly togather air at the top of reservoir (168) before advancing plunger (167)distally in order to purge air from reservoir (168).

Once reservoir (168) has been sufficiently filled with fluid and air hasbeen purged, the operator may couple inflator (150) with dilationcatheter (20), such as by coupling port (170) with lateral port (26) viaa flexible tube (46). With dilator (22) being suitably positioned withinan anatomical passageway (e.g., an ostium (O), etc.), the operator maythen advance plunger (167) distally in order to transfer fluid fromreservoir (168) to dilator (22). In some instances, this act may beginwith free translation of threaded shaft (166) relative to proximal cap(172), with the operator depressing push button (152) to disengage thethreading, and with the operator gripping actuator knob (164) totranslate threaded shaft (166) and plunger (167) distally. At somepoint, however, the operator may release push button (152) to engage thethreading of threaded shaft (166) with proximal cap (172), and mayfinish the final stages of distal translation of plunger (167) byrotating actuator knob (164). This may enable the operator to moreprecisely “dial in” the appropriate amount of pressure in dilator (22),observing the pressure reading at gauge (162) while rotating actuatorknob (164).

In some instances, the operator simply relies on tactile feedback in theform of physical resistance to pushing of actuator knob (164) in orderto determine the appropriate time to transition from pushing of actuatorknob (164) (with push button (152) depressed) to rotating of actuatorknob (164) (with push button (152) released). In addition or in thealternative, the operator may determine the appropriate time totransition from pushing of actuator knob (164) to rotating of actuatorknob (164) based on the position of plunger (167) relative to one ormore markings on body (160). Other suitable forms of feedback that maybe used to determine an appropriate transition time from pushing ofactuator knob (164) to rotating of actuator knob (164) will be apparentto those of ordinary skill in the art in view of the teachings herein.

Once the operator has attained the desired level of pressure in dilator(22) within the anatomical passageway to dilate the anatomicalpassageway, the operator may pause for an approximate, predeterminedperiod of time (e.g., approximately three seconds, etc.). The operatormay then once again depress push button (152) and pull knob (164)proximally relative to body (160), to thereby retract plunger (167) forwithdrawal of fluid from dilator (22). With dilator (22) now deflated,dilator (22) may be retracted from the patient. Alternatively, if theoperator wishes to dilate additional anatomical passageways, dilator(22) may be positioned in the next anatomical passageway, and theoperator may repeat the above steps to dilate that next anatomicalpassageway. Thus, the same volume of fluid within reservoir (168) may beused repeatedly to dilate a plurality of anatomical passageways, withouthaving to withdraw dilator (22) from the patient, and without having todecouple inflator (150) from the rest of dilator catheter system (10),until all of the desired dilations have been completed.

In the foregoing example, the threading of threaded shaft (166) isengaged with proximal cap (172) when push button (152) is not beingdepressed. In some other versions, the threading of threaded shaft (166)is engaged with proximal cap (172) only when push button (152) is beingdepressed. Other suitable variations of inflator (150) will be apparentto those of ordinary skill in the art in view of the teachings herein.Similarly, other suitable ways in which inflator (150) may he used willbe apparent to those of ordinary skill in the art in view of theteachings herein.

B. Exemplary Alternative Inflator with Knob and Rotary Thread Release

FIG. 7 shows another exemplary inflator (250). Inflator (250) of thisexample is substantially similar to inflator (150) described above withreference to FIG. 6. In particular, inflator (250) comprises a body(260), an actuator knob (264), and a pressure gauge (262). Body (260) ofthe present example is formed as a substantially hollow cylinder,similar to syringe barrel (42) described above, although other suitableconfigurations may be used. Body (260) comprises a reservoir (268), adistal port (270), and a rotary locking feature (252) at the proximalend of body (260). A rod (265) extends into body (260). Plunger (267) iscoupled to a distal end of rod (265) and extends outwardly to the innerdiameter of body (260) to form a substantially fluid tight seal withbody (260). The volume between plunger (267) and the distal end of body(260) forms reservoir (268). Reservoir (268) may be configured to holdabout 3 to about 5 cc of fluid (e.g., saline). Rod (265) and plunger(267) may translate proximally and distally to adjust the size ofreservoir (268). When rod (265) and plunger (267) translate proximally,the volume of reservoir (268) increases. When rod (265) and plunger(267) translate distally, the volume of reservoir (268) decreases. Port(270) at the distal end of body (260) is in fluid communication withreservoir (268) such that fluid may flow into and out of reservoir (268)via port (270). Port (270) may be coupled with flexible tube (46) ofdilator catheter system (10).

Actuator knob (264) is coupled to body (260) via a threaded shaft (266),which is in selective threaded engagement with rotary locking feature(252) of body (260). Threaded shaft (266) is configured to rotateunitarily with actuator knob (264). Thus, rotation of actuator knob(264) relative to body (260) will cause threaded shaft (266) totranslate relative to body (260) when the threading of threaded shaft(266) is engaged with rotary locking feature (252). Threaded shaft (266)is further coupled with rod (265) such that when actuator knob (264) isrotated relative to body (260), rod (265) and plunger (267) translateproximally or distally relative to body (265) based on the direction inwhich actuator knob (264) and threaded shaft (266) are rotated. In someversions, threaded shaft (266) and rod (265) are the same structure,such that threaded shaft (266) extends all the way to plunger (267). Insome such versions, threaded shaft (266) rotates freely relative toplunger (267).

In the present example, rotary locking feature (252) comprises anannular component that is rotatable relative to body (260) toselectively engage/disengage the threading of threaded shaft (266). Inparticular, rotary locking feature (252) is operable to selectivelydisengage the threading of threaded shaft (266), to thereby permitthreaded shaft (266) to translate freely relative to body (260) whenrotary locking feature (252) is rotated to an unlocked position. Varioussuitable features that may be used to provide such operability will beapparent to those of ordinary skill in the art in view of the teachingsherein. By way of example only, rotary locking feature (252) may includeretractable internal threading that is selectively engaged with theexternal threading of threaded shaft (266) based on the rotationalposition of rotary locking feature (252) relative to body (260). Asanother merely illustrative example, an internally threaded member maybe positioned within rotary locking feature (252), and rotary lockingfeature (252) may be configured to selectively secure the rotationalposition of this internally threaded member relative to body (260) basedon the rotational position of rotary locking feature (252) relative tobody (260). For instance, the internally threaded member may berotationally fixed relative to body (260) when rotary locking feature(252) is rotated to a locked position; while the internally threadedmember may rotate freely relative to body (260) when rotary lockingfeature (252) is rotated to an unlocked position. Still other suitablecomponents and configurations that may be used to provide theabove-described selective engagement between threaded shaft (266) andbody (260) will be apparent to those of ordinary skill in the art inview of the teachings herein.

In addition, body (260) and rotary locking feature (252) of the presentexample include complementary features to provide feedback to theoperator indicating whether rotary locking feature (252) is in thelocked or unlocked position. In particular, rotary locking feature (252)includes a graphical representation (253) of a padlock that aligns witha complementary indicator on body (260) when rotary locking feature(252) is in the locked position. In addition, body (260) and rotarylocking feature (252) have the same asymmetric cross-sectional shape.When rotary locking feature (252) is rotated to the locked position,these cross-sections align such that the outer surfaces of body androtary locking feature (252) are substantially flush with each other.When rotary locking feature (252) is rotated to the unlocked position,the cross-sections are not aligned and their non-alignment is visuallypronounced by the asymmetry of their cross-sections. In other words, thenon-alignment of the cross-sections is easy to observe visually andtactilely. Other suitable ways in which the locked/unlocked state ofrotary locking feature (252) may be indicated will be apparent to thoseof ordinary skill in the art in view of the teachings herein.

Gauge (262) of the present example is positioned distal of reservoir(268) to measure the pressure within dilator catheter system (10). Gauge(262) of this example comprises a digital pressure gauge with an LCD orLED screen providing the numerical value of the fluid pressure.Alternatively, gauge (262) may provide any other suitable type ofindication of fluid pressure, including but not limited to the othertypes of fluid pressure indication described herein. In the presentexample, gauge (262) is operable to indicate pressure levels up to atleast about 12 atmospheres. For instance, some uses of dilator cathetersystem (10) may include inflation of dilator (22) to a range betweenabout 10 atmospheres and about 12 atmospheres in order to sufficientlydilate a targeted anatomical passageway. Gauge (262) may thus providethe operator with real time feedback indicating the fluid pressurewithin dilator (22) to enable the operator to determine whether thedesired pressure level has been achieved.

In an exemplary use of inflator (250), a operator may start with plunger(267) advanced to a distal position in body (260). The operator may thenposition port (270) in a bowl or other container of saline to draw fluidfrom. In instances where port (270) is coupled with one end of flexibletube (46), the operator may position. the other end of flexible tube(46) in the saline. In either case, the operator may then retractplunger (267) relative to body (260) to draw the saline (or other fluid)into reservoir (268). In some instances, rotary locking feature (252) isrotated to the unlocked position at this stage, to disengage threadingof threaded shaft (266) relative to body (260), thereby permitting theoperator to freely pull plunger (267) proximally without having torotate actuator knob (264). The operator may nevertheless grasp actuatorknob (264) in order to translate plunger (267) proximally. The operatormay observe the position of plunger (267) relative to indicia on body(260) and may initially draw in more fluid than the operator expects toneed in order to sufficiently inflate dilator (22). The operator maythen remove port (270) or flexible tube (46) from the saline containerand advance plunger (267) distally in order to purge air from reservoir(268). For instance, the operator may orient inflator (250) such thatport (270) is positioned upwardly to gather air at the top of reservoir(268) before advancing plunger (267) distally in order to purge air fromreservoir (268).

Once reservoir (268) has been sufficiently filled with fluid and air hasbeen purged, the operator may couple inflator (250) with dilationcatheter (20), such as by coupling port (270) with lateral port (26) viaa flexible tube (46). With dilator (22) being suitably positioned withinan anatomical passageway (e.g., an ostium (O), etc.), the operator maythen advance plunger (267) distally in order to transfer fluid fromreservoir (268) to dilator (22). In some instances, this act may beginwith free translation of threaded shaft (266) relative to body (260),with rotary locking feature (252) being rotated to the unlocked positionto disengage the threading, and with the operator gripping actuator knob(264) to translate threaded shaft (266) and plunger (267) distally. Atsome point, however, the operator may rotate rotary locking feature(252) to the locked position, to engage the threading of threaded shaft(266) with body (260), and may finish the final stages of distaltranslation of plunger (267) by rotating actuator knob (264). This mayenable the operator to more precisely “dial in” the appropriate amountof pressure in dilator (22), observing the pressure reading at gauge(262) while rotating actuator knob (264).

In some instances, the operator simply relies on tactile feedback in theform of physical resistance to pushing of actuator knob (264) in orderto determine the appropriate time to transition from pushing of actuatorknob (264) (with rotary locking feature (252) in the unlocked position)to rotating of actuator knob (264) (with rotary locking feature (252) inthe locked position). In addition or in the alternative, the operatormay determine the appropriate time to transition from pushing ofactuator knob (264) to rotating of actuator knob (264) based on theposition of plunger (267) relative to one or more markings on body(260). Other suitable forms of feedback that may be used to determine anappropriate transition time from pushing of actuator knob (264) torotating of actuator knob (264) will be apparent to those of ordinaryskill in the art in view of the teachings herein.

Once the operator has attained the desired level of pressure in dilator(22) within the anatomical passageway to dilate the anatomicalpassageway, the operator may pause for an approximate, predeterminedperiod of time (e.g., approximately three seconds, etc.). The operatormay then once again rotate rotary locking feature (252) back to theunlocked position and pull knob (264) proximally relative to body (260),to thereby retract plunger (267) for withdrawal of fluid from dilator(22). With dilator (22) now deflated, dilator (22) may be retracted fromthe patient. Alternatively, if the operator wishes to dilate additionalanatomical passageways, dilator (22) may be positioned in the nextanatomical passageway, and the operator may repeat the above steps todilate that next anatomical passageway. Thus, the same volume of fluidwithin reservoir (268) may be used repeatedly to dilate a plurality ofanatomical passageways, without having to withdraw dilator (22) from thepatient, and without having to decouple inflator (250) from the rest ofdilator catheter system (10), until all of the desired dilations havebeen completed.

Other suitable variations of inflator (250) will be apparent to those ofordinary skill in the art in view of the teachings herein. Similarly,other suitable ways in which inflator (250) may he used will be apparentto those of ordinary skill in the art in view of the teachings herein.

C. Exemplary Alternative Inflator with Resiliently Biased Plunger

FIG. 8 shows another exemplary inflator (350). Inflator (350) of thisexample is configured for one-handed operation. Inflator (350) of thisexample comprises a body (360), an actuator (364), and a pressure gauge(362). Body (360) of the present example is formed as a substantiallyhollow cylinder, similar to syringe barrel (42) described above,although other suitable configurations may be used. Body (360) comprisesa reservoir (368), a distal port (370), and a handle (358) at theproximal end of body (360). A rod (365) extends into body (360). Plunger(367) is coupled to a distal end of rod (365) and extends outwardly tothe inner diameter of body (360) to form a substantially fluid tightseal with body (360). The volume between plunger (367) and the distalend of body (360) forms reservoir (368). Reservoir (368) may beconfigured to hold about 3 to about 5 cc of fluid (e.g., saline). Rod(365) and plunger (367) may translate proximally and distally to adjustthe size of reservoir (368). When rod (365) and plunger (367) translateproximally, the volume of reservoir (368) increases. When rod (365) andplunger (367) translate distally, the volume of reservoir (368)decreases. Port (370) at the distal end of body (360) is in fluidcommunication with reservoir (368) such that fluid may flow into and outof reservoir (368) via port (370). Port (370) may be coupled withflexible tube (46) of dilator catheter system (10).

Actuator (364) is unitarily secured to rod (365), such that actuator(364) and rod (365) (and, hence, plunger (367)) translate unitarilyrelative to body (360). A coil spring (356) is coaxially disposed aboutrod (365) and bears against both actuator (364) and body (360). Coilspring (356) thus resiliently biases actuator (364) proximally. Ofcourse, any other suitable type of resilient member may be used.Actuator (364) has a “T” shape that is configured to rest in the palm ofthe operator's hand. Handle (358) of body (360) is configured such thata operator may wrap his or her fingers around handle (358) with actuator(364) in the palm of the same hand. The operator may thus drive actuator(364) distally relative to handle (358) by squeezing with that singlehand. As the operator thereafter releases their grip, the resilient biasof coil spring (356) returns actuator (364) proximally relative tohandle (358). Plunger (367) translates relative to body (360)accordingly.

Gauge (362) of the present example is positioned distal of reservoir(368) to measure the pressure within dilator catheter system (10). Gauge(362) of this example comprises a digital pressure gauge with an LCD orLED screen providing the numerical value of the fluid pressure.Alternatively, gauge (362) may provide any other suitable type ofindication of fluid pressure, including but not limited to the othertypes of fluid pressure indication described herein. In the presentexample, gauge (362) is operable to indicate pressure levels up to atleast about 12 atmospheres. For instance, some uses of dilator cathetersystem (10) may include inflation of dilator (22) to a range betweenabout 10 atmospheres and about 12 atmospheres in order to sufficientlydilate a targeted anatomical passageway. Gauge (362) may thus providethe operator with real time feedback indicating the fluid pressurewithin dilator (22) to enable the operator to determine whether thedesired pressure level has been achieved.

In an exemplary use of inflator (350), a operator may start with plunger(367) advanced to a distal position in body (360). This may beaccomplished by squeezing actuator (364) toward handle (358) with asingle hand. The operator may then position port (370) in a bowl orother container of saline to draw fluid from. In instances where port(370) is coupled with one end of flexible tube (46), the operator mayposition the other end of flexible tube (46) in the saline. In eithercase, the operator may then release actuator (364) relative to handle(358). The resilient bias of coil spring (356) may cause actuator (364)and rod (365) to retract relative to body (360), which may in turnretract plunger (367) relative to body (360) to draw the saline (orother fluid) into reservoir (368). The operator may then remove port(370) or flexible tube (46) from the saline container and advanceplunger (367) distally in order to purge air from reservoir (368). Forinstance, the operator may orient inflator (350) such that port (370) ispositioned upwardly to gather air at the top of reservoir (368) beforeadvancing plunger (367) distally in order to purge air from reservoir(368).

Once reservoir (368) has been sufficiently filled with fluid and air hasbeen purged, the operator may couple inflator (350) with dilationcatheter (20), such as by coupling port (370) with lateral port (26) viaa flexible tube (46). With dilator (22) being suitably positioned withinan anatomical passageway (e.g., an ostium (O), etc.), the operator maythen advance actuator (364) distally by squeezing actuator (364) andhandle (358) with a single hand, in order to transfer fluid fromreservoir (368) to dilator (22). The operator may observe the pressurereading at gauge (362) while advancing actuator (364) distally in orderto determine when the appropriate fluid pressure level has been reached.

Once the operator has attained the desired level of pressure in dilator(22) within the anatomical passageway to dilate the anatomicalpassageway, the operator may pause for an approximate, predeterminedperiod of time (e.g., approximately three seconds, etc.). The operatormay then release their grip on actuator (364) to allow coil spring (356)to translate actuator (364) and rod (365) proximally, to thereby retractplunger (267) for withdrawal of fluid from dilator (22). With dilator(22) now deflated, dilator (22) may be retracted from the patient.Alternatively, if the operator wishes to dilate additional anatomicalpassageways, dilator (22) may be positioned in the next anatomicalpassageway, and the operator may repeat the above steps to dilate thatnext anatomical passageway. Thus, the same volume of fluid withinreservoir (368) may be used repeatedly to dilate a plurality ofanatomical passageways, without having to withdraw dilator (22) from thepatient, and without having to decouple inflator (350) from the rest ofdilator catheter system (10), until all of the desired dilations havebeen completed.

In some instances, rod (365) and body (360) include complementary detentfeatures (and/or some other type of feature(s)) that provide theoperator with audible and/or tactile feedback. For instance, suchfeatures may provide the operator with feedback to indicate longitudinalpositions of plunger (367) that are predeterminedly associated with anappropriate pressure level in dilator (22). In addition or in thealternative, such features may provide the operator with feedback toindicate that the longitudinal position of plunger (367) is gettingclose to a position that is predeterminedly associated with anappropriate pressure level in dilator (22), thereby alerting theoperator to slow their distal advancement of actuator (364) andcarefully watch gauge (362). Detent features (and/or some other type offeature(s)) may also provide the operator with audible and/or tactilefeedback to indicate when plunger (367) has reached a position that ispredeterminedly associated with air being purged from reservoir (368)before port (370) is coupled with lateral port (26). As yet anothermerely illustrative variation, some versions may provide a manuallocking feature that enables the operator to selectively secure theposition of actuator (364) relative to body—either at one or morepredetermined positions and/or at positions selected ad hoc by theoperator. Other suitable variations of inflator (350) will be apparentto those of ordinary skill in the art in view of the teachings herein.Similarly, other suitable ways in which inflator (350) may be used willbe apparent to those of ordinary skill in the art in view of theteachings herein.

D. Exemplary Alternative Inflator with Lever Actuated CrankshaftAssembly

FIG. 9 shows another exemplary inflator (450). Inflator (450) of thisexample comprises a body (460), a pair of actuator levers (464), and apressure gauge (462). Body (460) of the present example is formed as asubstantially hollow cylinder, similar to syringe barrel (42) describedabove, although other suitable configurations may be used. Body (460)comprises a reservoir (468), a distal port (470), and a crank shaftassembly (451) at the proximal end of body (460). A rod (465) islongitudinally driven by crank shaft assembly (451) as described ingreater detail below. Plunger (467) is coupled to a distal end of rod(465) and extends outwardly to the inner diameter of body (460) to forma substantially fluid tight seal with body (460). The volume betweenplunger (467) and the distal end of body (460) forms reservoir (468).Reservoir (468) may be configured to hold about 3 to about 5 cc of fluid(e.g., saline). Rod (465) and plunger (467) may translate proximally anddistally to adjust the size of reservoir (468). When rod (465) andplunger (467) translate proximally, the volume of reservoir (468)increases. When rod (465) and plunger (467) translate distally, thevolume of reservoir (468) decreases. Port (470) at the distal end ofbody (460) is in fluid communication with reservoir (468) such thatfluid may flow into and out of reservoir (468) via port (470). Port(470) may be coupled with flexible tube (46) of dilator catheter system(10).

Crank shaft assembly (451) comprises a crank shaft (452) and a crankwheel (454). Crank shaft (452) and crank wheel (454) are coaxial witheach other and rotate unitarily with each other. Actuator levers (464)are secured to opposing ends of crank shaft (452). Actuator levers (464)are operable to rotate crank shaft (452) and crank wheel (454) relativeto body (460), about the axis shared by crank shaft (452) and crankwheel (454). As best seen in FIG. 10, crank wheel (454) includes anintegral crank pin (455) that extends along an axis that is offset fromthe axis shared by crank shaft (452) and crank wheel (454). In otherwords, crank pin (455) is off center relative to crank wheel (454). Oneend of a connecting rod (456) is pivotally coupled with crank pin (455),while the other end of connecting rod (456) is pivotally coupled with apin (457) at the head (458) of rod (465). These couplings may includebushings, bearings, and/or other features to provide smooth pivotingmovement of connecting rod (456) relative to crank wheel (454) and head(458). It should be understood that the configuration of crank shaftassembly (451) will provide reciprocation of rod (465) and plunger (467)in response to rotation of actuator levers (464) relative to body (460).It should also be understood that positioning of actuator levers (464)on both sides of body (460) may facilitate use by both left-handed andright-handed operators.

In the present example, actuator levers (464), crank shaft (452), andcrank wheel (454) are operable to rotate through a range ofapproximately 150°. Alternatively, any other suitable angular range maybe provided. In instances providing a limited angular range, the limitsmay be imposed by bosses or other features that provide hard stopspreventing rotation of actuator levers (464), crank shaft (452), andcrank wheel (454) beyond the predetermined range. As shown in FIG. 10,there are three predetermined angular positions within therange—position “A,” position “B,” and position “C.” These angularpositions are associated with the location of crank pin (455) atparticular stages of use of inflator (450) as will be described ingreater detail below. It should be understood that inflator (450) mayinclude detent features (and/or some other type of feature(s)) thatprovide the operator with audible and/or tactile feedback to indicatearrival at position “A,” position “B,” and/or position “C.” In someother versions, a detent feature is only used to indicate arrival atposition “B,” while hard stops indicate arrival at position “A” andposition “B.” Other suitable forms of feedback will be apparent to thoseof ordinary skill in the art in view of the teachings herein.

Gauge (462) of the present example is positioned at the proximal end ofbody (460), and includes a pivoting pin (463) that indicates fluidpressure based on the angular position of the pin. Alternatively, gauge(462) may provide any other suitable type of indication of fluidpressure. By way of example only, gauge (462) may be substituted withthe gauge (472) shown in FIG. 11, which includes a longitudinallysliding pressure indicator (474) similar to a conventional tire pressuregauge. As another merely illustrative alternative, gauge (462) may besubstituted with the gauge (482) shown in FIG. 12, which includes adigital display (484) showing the pressure reading in numerical form.Other suitable forms that gauge (462) may take will be apparent to thoseof ordinary skill in the art in view of the teachings herein. In thepresent example, gauge (462) is operable to indicate pressure levels upto at least about 12 atmospheres. For instance, some uses of dilatorcatheter system (10) may include inflation of dilator (22) to a rangebetween about 10 atmospheres and about 12 atmospheres in order tosufficiently dilate a targeted anatomical passageway. Gauge (462) maythus provide the operator with real time feedback indicating the fluidpressure within dilator (22) to enable the operator to determine whetherthe desired pressure level has been achieved.

In an exemplary use of inflator (450), a operator may start withactuator levers (464) at a position corresponding to crank pin (455)being located at position “A,” which further corresponds to plunger(467) being at a distal position in body (460). The operator may thenposition port (470) in a bowl or other container of saline to draw fluidfrom. In instances where port (470) is coupled with one end of flexibletube (46), the operator may position the other end of flexible tube (46)in the saline. In either case, the operator may then pivot actuatorlevers (464) to a position corresponding to crank pin (455) beinglocated at position “C,” which further corresponds to plunger (467)being at a proximal position in body (460). This proximal movement ofplunger (467) draws the saline (or other fluid) into reservoir (468).The operator may then remove port (470) or flexible tube (46) from thesaline container and pivot actuator levers (464) to a positioncorresponding to crank pin (455) being located at position “B,” whichfurther corresponds to plunger (467) being at an intermediate positionin body (460). It should be understood that transitioning crank pin(455) from position “A” to position “C” will entail pivoting actuatorlevers (464) in a first direction; while transitioning crank pin (455)from position “C” to position “B” will entail pivoting actuator levers(464) in a second direction. It should also be understood that thedistal movement of plunger (467) resulting from the transition of crankpin (455) from position “C” to position “B” may purge air from reservoir(468). For instance, the operator may orient inflator (450) such thatport (470) is positioned upwardly to gather air at the top of reservoir(468) before advancing plunger (467) distally in order to purge air fromreservoir (468).

Once reservoir (468) has been sufficiently filled with fluid and air hasbeen purged, the operator may couple inflator (450) with dilationcatheter (20), such as by coupling port (470) with lateral port (26) viaa flexible tube (46). With dilator (22) being suitably positioned withinan anatomical passageway (e.g., an ostium (O), etc.), the operator maythen pivot actuator levers (464) to a position corresponding to crankpin (455) being located back at position “A,” which again corresponds toplunger (467) being at a distal position in body (460). This drivesfluid from reservoir (468) to dilator (22) to thereby inflate dilator(22). In some instances, the volumes are all known and predetermined,such that dilator (22) always reaches an appropriate pressure level assoon as plunger (467) reaches a position associated with crank pin (455)being located at position “A.” Thus, in some such versions, gauge (462)may be omitted. In some other versions, inflator (450) may permit a finelevel of fluid pressure adjustment, via levers (464) or otherwise, afterplunger (467) reaches a position associated with crank pin (455) beinglocated at position “A.”

Once the operator has attained the desired level of pressure in dilator(22) within the anatomical passageway to dilate the anatomicalpassageway, the operator may pause for an approximate, predeterminedperiod of time (e.g., approximately three seconds, etc.). The operatormay then once again pivot levers (464) to move crank pin (455) back toposition “B,” which will cause plunger (467) to retract back to theintermediate position, which will in turn withdraw the fluid fromdilator (22). With dilator (22) now deflated, dilator (22) may beretracted from the patient. Alternatively, if the operator wishes todilate additional anatomical passageways, dilator (22) may be positionedin the next anatomical passageway, and the operator may repeat the abovesteps to dilate that next anatomical passageway. Thus, the same volumeof fluid within reservoir (468) may be used repeatedly to dilate aplurality of anatomical passageways, without having to withdraw dilator(22) from the patient, and without having to decouple inflator (450)from the rest of dilator catheter system (10), until all of the desireddilations have been completed.

Other suitable variations of inflator (450) will be apparent to those ofordinary skill in the art in view of the teachings herein. Similarly,other suitable ways in which inflator (450) may be used will be apparentto those of ordinary skill in the art in view of the teachings herein.

E. Exemplary Alternative Inflator with Knob Actuated Crankshaft

FIG. 13 shows another exemplary inflator (550), which is substantiallysimilar to inflator (450) described above. Inflator (550) of thisexample comprises a body (560), an actuator knob (564), and a pressuregauge (562). Body (560) of the present example is formed as asubstantially hollow cylinder, similar to syringe barrel (42) describedabove, although other suitable configurations may be used. Body (560)comprises a reservoir (568), a distal port (570), and a crank shaftassembly (551) at the proximal end of body (560). A rod (565) islongitudinally driven by crank shaft assembly (551) in a manner similarto rod (465) being driven by crank shaft assembly (451) described above.Plunger (567) is coupled to a distal end of rod (565) and extendsoutwardly to the inner diameter of body (560) to form a substantiallyfluid tight seal with body (560). The volume between plunger (567) andthe distal end of body (560) forms reservoir (568). Reservoir (568) maybe configured to hold about 3 to about 5 cc of fluid (e.g., saline). Rod(565) and plunger (567) may translate proximally and distally to adjustthe size of reservoir (568). When rod (565) and plunger (567) translateproximally, the volume of reservoir (568) increases. When rod (565) andplunger (567) translate distally, the volume of reservoir (568)decreases. Port (570) at the distal end of body (560) is in fluidcommunication with reservoir (568) such that fluid may flow into and outof reservoir (568) via port (570). Port (570) may be coupled withflexible tube (46) of dilator catheter system (10).

Crank shaft assembly (551) comprises a crank shaft (552) and a crankwheel (554). Crank shaft (552) and crank wheel (554) are coaxial witheach other and rotate unitarily with each other. Actuator knob (564) issecured to one end of crank shaft (552). In some other versions, anadditional actuator knob (564) may be secured to the other end of crankshaft (552). Actuator knob (564) is operable to rotate crank shaft (552)and crank wheel (554) relative to body (560), about the axis shared bycrank shaft (552) and crank wheel (554). A connecting rod (556) ispivotally coupled with an off center crank pin of crank wheel (554); andis further pivotally coupled with a pin at the head (558) of rod (565).These couplings may include bushings, bearings, and/or other features toprovide smooth pivoting movement of connecting rod (556) relative tocrank wheel (554) and head (558). It should be understood that theconfiguration of crank shaft assembly (551) will provide reciprocationof rod (565) and plunger (567) in response to rotation of actuator knob(564) relative to body (560).

In the present example, actuator knob (564), crank shaft (552), andcrank wheel (554) are operable to rotate through a range ofapproximately 150°. Alternatively, any other suitable angular range maybe provided. In instances providing a limited angular range, the limitsmay be imposed by bosses or other features that provide hard stopspreventing rotation of actuator knob (564), crank shaft (552), and crankwheel (554) beyond the predetermined range. in some versions, there arethree predetermined angular positions within the range—such as positionssubstantially similar to position “A,” position “B,” and position “C”shown in FIG. 10. These angular positions are associated with thelocation of the crank pin at particular stages of use of inflator (550)as will be described in greater detail below. It should be understoodthat inflator (550) may include detent features (and/or some other typeof feature(s)) that provide the operator with audible and/or tactilefeedback to indicate arrival at position “A,” position “B,” and/orposition “C.” In some other versions, a detent feature is only used toindicate arrival at position “B,” while hard stops indicate arrival atposition “A” and position “B.” Other suitable forms of feedback will beapparent to those of ordinary skill in the art in view of the teachingsherein.

Gauge (562) of the present example is positioned at the proximal end ofbody (560), and includes a pivoting pin (563) that indicates fluidpressure based on the angular position of the pin. Alternatively, gauge(562) may provide any other suitable type of indication of fluidpressure, including but not limited to the other types of fluid pressureindication described herein. In the present example, gauge (562) isoperable to indicate pressure levels up to at least about 12atmospheres. For instance, some uses of dilator catheter system (10) mayinclude inflation of dilator (22) to a range between about 10atmospheres and about 12 atmospheres in order to sufficiently dilate atargeted anatomical passageway. Gauge (562) may thus provide theoperator with real time feedback indicating the fluid pressure withindilator (22) to enable the operator to determine whether the desiredpressure level has been achieved.

In an exemplary use of inflator (550), a operator may start withactuator knob (564) at a position corresponding to the crank pin beinglocated at position “A,” which further corresponds to plunger (567)being at a distal position in body (560). The operator may then positionport (570) in a bowl or other container of saline to draw fluid from. Ininstances where port (570) is coupled with one end of flexible tube(46), the operator may position the other end of flexible tube (46) inthe saline. In either case, the operator may then rotate actuator knob(564) to a position corresponding to the crank pin being located atposition “C,” which further corresponds to plunger (567) being at aproximal position in body (560). This proximal movement of plunger (567)draws the saline (or other fluid) into reservoir (568). The operator maythen remove port (570) or flexible tube (46) from the saline containerand rotate actuator knob (564) to a position corresponding to the crankpin being located at position “B,” which further corresponds to plunger(567) being at an intermediate position in body (560). It should beunderstood that transitioning the crank pin from position “A” toposition “C” will entail rotating actuator knob (564) in a firstdirection; while transitioning the crank pin from position “C” toposition “B” will entail rotating actuator knob (564) in a seconddirection. It should also be understood that the distal movement ofplunger (567) resulting from the transition of the crank pin fromposition “C” to position “B” may purge air from reservoir (568). Forinstance, the operator may orient inflator (550) such that port (570) ispositioned upwardly to gather air at the top of reservoir (568) beforeadvancing plunger (567) distally in order to purge air from reservoir(568).

Once reservoir (568) has been sufficiently filled with fluid and air hasbeen purged, the operator may couple inflator (550) with dilationcatheter (20), such as by coupling port (570) with lateral port (26) viaa flexible tube (46). With dilator (22) being suitably positioned withinan anatomical passageway (e.g., an ostium (O), etc.), the operator maythen rotate actuator knob (564) to a position corresponding to the crankpin being located back at position “A,” which again corresponds toplunger (567) being at a distal position in body (560). This drivesfluid from reservoir (568) to dilator (22) to thereby inflate dilator(22). In some instances, the volumes are all known and predetermined,such that dilator (22) always reaches an appropriate pressure level assoon as plunger (567) reaches a position associated with the crank pinbeing located at position “A.” Thus, in some such versions, gauge (562)may be omitted. In some other versions, inflator (550) may permit a finelevel of fluid pressure adjustment, via knob (564) or otherwise, afterplunger (567) reaches a position associated with the crank pin beinglocated at position “A.”

Once the operator has attained the desired level of pressure in dilator(22) within the anatomical passageway to dilate the anatomicalpassageway, the operator may pause for an approximate, predeterminedperiod of time (e.g., approximately three seconds, etc.). The operatormay then once again rotate knob (564) to move the crank pin back toposition “B,” which will cause plunger (567) to retract back to theintermediate position, which will in turn withdraw the fluid fromdilator (22). With dilator (22) now deflated, dilator (22) may beretracted from the patient. Alternatively, if the operator wishes todilate additional anatomical passageways, dilator (22) may be positionedin the next anatomical passageway, and the operator may repeat the abovesteps to dilate that next anatomical passageway. Thus, the same volumeof fluid within reservoir (568) may be used repeatedly to dilate aplurality of anatomical passageways, without having to withdraw dilator(22) from the patient, and without having to decouple inflator (550)from the rest of dilator catheter system (10), until all of the desireddilations have been completed.

Other suitable variations of inflator (550) will be apparent to those ofordinary skill in the art in view of the teachings herein. Similarly,other suitable ways in which inflator (550) may be used will be apparentto those of ordinary skill in the art in view of the teachings herein.

F. Exemplary Alternative Inflator with Knob Actuated Eccentric Cam

FIG. 14 depicts another exemplary inflator (650). Inflator (650) of thisexample comprises a body (660), an actuator knob (664), and a pressuregauge (662). Body (660) of the present example is formed as asubstantially hollow cylinder, similar to syringe barrel (42) describedabove, although other suitable configurations may be used. Body (660)comprises a reservoir (668), a distal port (670), and a cam driveassembly (651) at the proximal end of body (660). A rod (665) islongitudinally driven by cam drive assembly (651) as will be describedin greater detail below. Plunger (667) is coupled to a distal end of rod(665) and extends outwardly to the inner diameter of body (660) to forma substantially fluid tight seal with body (660). The volume betweenplunger (667) and the distal end of body (660) forms reservoir (668).Reservoir (668) may be configured to hold about 3 to about 5 cc of fluid(e.g., saline). Rod (665) and plunger (667) may translate proximally anddistally to adjust the size of reservoir (668). When rod (665) andplunger (667) translate proximally, the volume of reservoir (668)increases. When rod (665) and plunger (667) translate distally, thevolume of reservoir (668) decreases. Port (670) at the distal end ofbody (660) is in fluid communication with reservoir (668) such thatfluid may flow into and out of reservoir (668) via port (670). Port(670) may be coupled with flexible tube (46) of dilator catheter system(10).

Cam drive assembly (651) comprises a cam shaft (652) and a rotary cam(654). Cam shaft (652) and rotary cam (654) rotate unitarily with eachother. Actuator knob (664) is secured to one end of cam shaft (652). Insome other versions, an additional actuator knob (664) may be secured tothe other end of cam shaft (652). Actuator knob (664) is operable torotate cam shaft (652) and rotary cam (654) relative to body (660),about the axis defined by cam shaft (652). Rotary cam (654) has anasymmetric profile that includes a round section and a flat section.Rotary cam (654) is also eccentrically disposed relative to thelongitudinal axis of cam shaft (652). The outer perimeter of rotary cam(654) is positioned to engage a cam plate (658), which is secured to theproximal end of rod (665). A coil spring (656) resiliently biases rod(665) proximally, thereby urging cam plate (658) into engagement withrotary cam (654). While coil spring (656) is located in reservoir (668)in the present example, it should be understood that coil spring (656)may be located elsewhere. For instance, coil spring (656) may bepositioned above cam plate (658), and may pull cam plate (658) intoengagement with rotary cam (654) instead of pushing cam plate (658) intoengagement with rotary cam (654). It should also be understood that anyother suitable type of component(s) may be used to provide a resilientbias to cam plate (658), in addition to or in lieu of coil spring (656).In some other versions, a torsion spring is coupled to cam shaft (652)and coil spring (656) is omitted.

In the present example, the asymmetric profile of rotary cam (654) andthe eccentric positioning of rotary cam (654) on cam shaft (652) providetranslation of cam plate (658), and thereby translation of rod (665) andplunger (667), in response to rotation of knob (664). In some versions,rotary cam (654) includes flats along its perimeter, with such flatscorresponding to certain stages of use of inflator (650) similar tothose associated with crank pin positions “A,” “B,” and “C,” describedabove with respect to inflators (450, 550). These flats may also providetactile feedback to the operator. For instance, as the operator rotatesknob (664) to transition from one stage to another, the operator mayfeel a slight resistance as rotary cam (654) bears against cam plate(658) during the transition from one flat of rotary cam (654) to thenext flat. Once the next flat reaches cam plate (658), knob (664) mayeffectively come to an abrupt stop, providing a sudden change in forcerequired for further rotation. The operator may thus sense the arrivalat the next operational stage by feeling the change in force throughknob (664). Other suitable forms of feedback will be apparent to thoseof ordinary skill in the art in view of the teachings herein.

Gauge (662) of the present example is positioned at the proximal end ofbody (660), and includes a pivoting pin (663) that indicates fluidpressure based on the angular position of the pin. Alternatively, gauge(662) may provide any other suitable type of indication of fluidpressure, including but not limited to the other types of fluid pressureindication described herein. In the present example, gauge (662) isoperable to indicate pressure levels up to at least about 12atmospheres. For instance, some uses of dilator catheter system (10) mayinclude inflation of dilator (22) to a range between about 10atmospheres and about 12 atmospheres in order to sufficiently dilate atargeted anatomical passageway. Gauge (662) may thus provide theoperator with real time feedback indicating the fluid pressure withindilator (22) to enable the operator to determine whether the desiredpressure level has been achieved.

In an exemplary use of inflator (650), a operator may start withactuator knob (664) at a position corresponding to plunger (667) beinglocated at a distal position in body (660). The operator may thenposition port (670) in a bowl or other container of saline to draw fluidfrom. In instances where port (670) is coupled with one end of flexibletube (46), the operator may position the other end of flexible tube (46)in the saline. In either case, the operator may then rotate actuatorknob (664) to a position corresponding to plunger (667) being located ata proximal position in body (660). In particular, this rotation of knob(664) repositions rotary cam (654) such that a flat or other perimeterfeature provides clearance for cam plate (658) to travel proximally,which cam plate (658) does under the resilient bias provided by spring(656). The resulting proximal movement of plunger (667) draws the saline(or other fluid) into reservoir (668). The interaction between cam plate(658) and a flat or other feature on rotary cam (654) may providetactile feedback to the operator via knob (664), indicating that plunger(667) has reached the proximal position. The operator may then removeport (670) or flexible tube (46) from the saline container and rotateactuator knob (664) to a position corresponding to plunger (667) beinglocated at a longitudinally intermediate position in body (660). Again,this rotation of knob (664) repositions rotary cam (654) such that aperimeter feature of rotary cam (654) drives cam plate (658) distally.The resulting distal movement of plunger (667) may purge air fromreservoir (668). For instance, the operator may orient inflator (650)such that port (670) is positioned upwardly to gather air at the top ofreservoir (668) before advancing plunger (667) distally in order topurge air from reservoir (668). The interaction between cam plate (658)and a flat or other feature on rotary cam (654) may provide tactilefeedback to the operator via knob (664), indicating that plunger (667)has reached the intermediate position.

Once reservoir (668) has been sufficiently filled with fluid and air hasbeen purged, the operator may couple inflator (650) with dilationcatheter (20), such as by coupling port (670) with lateral port (26) viaa flexible tube (46). With dilator (22) being suitably positioned withinan anatomical passageway (e.g., an ostium (O), etc.), the operator maythen rotate actuator knob (664) to a position corresponding to plunger(667) being at a distal position in body (660). Again, this rotation ofknob (664) repositions rotary cam (654) such that a perimeter feature ofrotary cam (654) drives cam plate (658) distally. The resulting distalmovement of plunger (667) drives fluid from reservoir (668) to dilator(22) to thereby inflate dilator (22). The interaction between cam plate(658) and a flat or other feature on rotary cam (654) may providetactile feedback to the operator via knob (664), indicating that plunger(667) has reached the distal position. In some instances, the volumesare all known and predetermined, such that dilator (22) always reachesan appropriate pressure level as soon as rotary cam (654) reaches aposition where plunger (667) is driven to a distal-most position. Thus,in some such versions, gauge (662) may be omitted. In some otherversions, inflator (650) may permit a fine level of fluid pressureadjustment, via knob (664) or otherwise, after plunger (667) is drivento a distal position associated by rotary cam (654).

Once the operator has attained the desired level of pressure in dilator(22) within the anatomical passageway to dilate the anatomicalpassageway, the operator may pause for an approximate, predeterminedperiod of time (e.g., approximately three seconds, etc.). The operatormay then once again rotate knob (664) to cause plunger (667) to retractback to the intermediate position, which will in turn withdraw the fluidfrom dilator (22). With dilator (22) now deflated, dilator (22) may beretracted from the patient. Alternatively, if the operator wishes todilate additional anatomical passageways, dilator (22) may be positionedin the next anatomical passageway, and the operator may repeat the abovesteps to dilate that next anatomical passageway. Thus, the same volumeof fluid within reservoir (668) may be used repeatedly to dilate aplurality of anatomical passageways, without having to withdraw dilator(22) from the patient, and without having to decouple inflator (650)from the rest of dilator catheter system (10), until all of the desireddilations have been completed.

Other suitable variations of inflator (650) will be apparent to those ofordinary skill in the art in view of the teachings herein. Similarly,other suitable ways in which inflator (650) may be used will be apparentto those of ordinary skill in the art in view of the teachings herein.

G. Exemplary Alternative Inflator with Palm Grip and Thumb Drive

FIG. 15 depicts another exemplary inflator (750). Inflator (750) of thisexample is configured for one-handed operation. Inflator (750) of thisexample comprises a body (760), an actuator (764), and a pressure gauge(762). Body (760) of the present example is formed as a substantiallyhollow cylinder, similar to syringe barrel (42) described above,although other suitable configurations may be used. Body (760) comprisesa reservoir (768), a distal port (770), and a handle (758) at theproximal end of body (760). A rod (765) extends into body (760). Plunger(767) is coupled to a distal end of rod (765) and extends outwardly tothe inner diameter of body (760) to form a substantially fluid tightseal with body (760). The volume between plunger (767) and the distalend of body (760) forms reservoir (768). Reservoir (768) may beconfigured to hold about 3 to about 5 cc of fluid (e.g., saline). Rod(765) and plunger (767) may translate proximally and distally to adjustthe size of reservoir (768). When rod (765) and plunger (767) translateproximally, the volume of reservoir (768) increases. When rod (765) andplunger (767) translate distally, the volume of reservoir (768)decreases. Port (770) at the distal end of body (760) is in fluidcommunication with reservoir (768) such that fluid may flow into and outof reservoir (768) via port (770). Port (770) may be coupled withflexible tube (46) of dilator catheter system (10).

Actuator (764) is unitarily secured to rod (765), such that actuator(764) and rod (765) (and, hence, plunger (767)) translate unitarilyrelative to body (760). In some versions, a coil spring (not shown)and/or some other type of resilient member resiliently biases actuator(764) proximally, though this is of course merely optional. Actuator(764) includes a ring that is configured to receive a operator's thumb.Handle (758) of body (760) is configured such that a operator may wraphis or her fingers around handle (758) with the thumb of the same handbeing disposed in the ring of actuator (764). The operator may thusdrive actuator (764) distally relative to handle (758), and retractactuator (764) proximally relative to handle (758), using just thatsingle hand. Plunger (767) translates relative to body (760)accordingly.

Inflator (750) of this example also includes a lock/unlock button (754)positioned near handle (758). It should he understood that button (754)may be positioned such that it can be actuated by the same single handthat is being used to hold handle (758) and drive actuator (764),without that hand having to be repositioned to transition among any ofthose operations. In some versions, inflator (750) includes a lockingassembly that will lock the longitudinal position of actuator (764), rod(765), and plunger (767) relative to body (760) unless button (754) isbeing depressed. For instance, at least part of rod (765) may includesawteeth and/or some other locking feature(s) that are engaged by a pawlor other type of ratcheting feature. The pawl or other type ofratcheting feature may be resiliently biased to engage that part of rod(765), such that the longitudinal position of actuator (764), rod (765),and plunger (767) relative to body (760) will be locked by default. Whenthe operator wishes to translate actuator (764), rod (765), and plunger(767) relative to body (760), the operator presses button (754) torelease the pawl or other type of ratcheting feature from the lockingfeature(s) of rod (765). Once the desired longitudinal position has beenreached, the operator may release button (754) to selectively lockactuator (764), rod (765), and plunger (767) at the longitudinalposition. As another merely illustrative example, actuator (764), rod(765), and plunger (767) may be configured to translate freely relativeto body (760) by default, and button (754) may be configured to lock thelongitudinal position of actuator (764), rod (765), and plunger (767)when button (754) is being depressed. Button (754) may thus serve as abrake in such instances. Various suitable ways in which button (754) mayselectively lock and/or unlock the longitudinal position of actuator(764), rod (765), and plunger (767) relative to body (760) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

Gauge (762) of the present example is positioned proximal to reservoir(768) and is configured to measure the pressure within dilator cathetersystem (10), Gauge (762) of this example comprises a U-tube type ofliquid column gauge or manometer. Graduated markings adjacent to theliquid column in gauge (762) indicate the numerical value of the fluidpressure. Alternatively, gauge (762) may provide any other suitable typeof indication of fluid pressure, including but not limited to the othertypes of fluid pressure indication described herein. In the presentexample, gauge (762) is operable to indicate pressure levels up to atleast about 12 atmospheres. For instance, some uses of dilator cathetersystem (10) may include inflation of dilator (22) to a range betweenabout 10 atmospheres and about 12 atmospheres in order to sufficientlydilate a targeted anatomical passageway. Gauge (762) may thus providethe operator with real time feedback indicating the fluid pressurewithin dilator (22) to enable the operator to determine whether thedesired pressure level has been achieved.

In an exemplary use of inflator (750), a operator may start with plunger(767) advanced to a distal position in body (760). This may beaccomplished by driving actuator (764) toward handle (758) with theoperator's thumb. The operator may then position port (770) in a bowl orother container of saline to draw fluid from. In instances where port(770) is coupled with one end of flexible tube (46), the operator mayposition the other end of flexible tube (46) in the saline. In eithercase, the operator may then pull actuator (764) proximally relative tohandle (758) with the operator's thumb. This will in turn retractplunger (767) relative to body (760) to draw the saline (or other fluid)into reservoir (768). The operator may then remove port (770) orflexible tube (46) from the saline container and advance plunger (767)distally in order to purge air from reservoir (768). For instance, theoperator may orient inflator (750) such that port (770) is positionedupwardly to gather air at the top of reservoir (768) before advancingplunger (767) distally in order to purge air from reservoir (768).

Once reservoir (768) has been sufficiently filled with fluid and air hasbeen purged, the operator may couple inflator (750) with dilationcatheter (20), such as by coupling port (770) with lateral port (26) viaa flexible tube (46). With dilator (22) being suitably positioned withinan anatomical passageway (e.g., an ostium (O), etc.), the operator maythen drive actuator (764) distally toward handle (758) with theoperator's thumb, in order to transfer fluid from reservoir (768) todilator (22). The operator may observe the pressure reading at gauge(762) while advancing actuator (764) distally in order to determine whenthe appropriate fluid pressure level has been reached.

Once the operator has attained the desired level of pressure in dilator(22) within the anatomical passageway to dilate the anatomicalpassageway, the operator may pause for an approximate, predeterminedperiod of time (e.g., approximately three seconds, etc.). The operatormay then pull actuator (764) proximally relative to handle (758) withthe operator's thumb. This will in turn retract plunger (767) relativeto body (760) to draw fluid from dilator (22). With dilator (22) nowdeflated, dilator (22) may be retracted from the patient. Alternatively,if the operator wishes to dilate additional anatomical passageways,dilator (22) may be positioned in the next anatomical passageway, andthe operator may repeat the above steps to dilate that next anatomicalpassageway. Thus, the same volume of fluid within reservoir (768) may beused repeatedly to dilate a plurality of anatomical passageways, withouthaving to withdraw dilator (22) from the patient, and without having todecouple inflator (750) from the rest of dilator catheter system (10),until all of the desired dilations have been completed.

In some instances, rod (765) and body (760) include complementary detentfeatures (and/or some other type of feature(s)) that provide theoperator with audible and/or tactile feedback. For instance, suchfeatures may provide the operator with feedback to indicate longitudinalpositions of plunger (767) that are predeterminedly associated with anappropriate pressure level in dilator (22). In addition or in thealternative, such features may provide the operator with feedback toindicate that the longitudinal position of plunger (767) is gettingclose to a position that is predeterminedly associated with anappropriate pressure level in dilator (22), thereby alerting theoperator to slow their distal advancement of actuator (764) andcarefully watch gauge (762). Detent features (and/or some other type offeature(s)) may also provide the operator with audible and/or tactilefeedback to indicate when plunger (767) has reached a position that ispredeterminedly associated with air being purged from reservoir (768)before port (770) is coupled with lateral port (26). Other suitablevariations of inflator (750) will be apparent to those of ordinary skillin the art in view of the teachings herein. Similarly, other suitableways in which inflator (750) may be used will be apparent to those ofordinary skill in the art in view of the teachings herein.

H. Exemplary Alternative Inflator with Rotary Drive and Button Release

FIGS. 16-20C depict another exemplary inflator (850). Inflator (850) ofthis example includes a housing (860), a syringe barrel (880), and aplunger actuation assembly (900). Housing (860) is formed by two halves(860 a, 860 b) that are joined together to contain syringe barrel (880)and plunger actuation assembly (900). As best seen in FIGS. 16-18, eachhalf (860 a, 860 b) includes a window (862) that permits viewing ofsyringe barrel (880). In particular, a operator of inflator (850) maysee how much fluid is in syringe barrel (880) by viewing syringe barrel(880) through window (862). As best seen in FIG. 18, each half (860 a,860 b) also includes a respective helically oriented groove (864) andflange recess (866). Grooves (864) of halves (860 a, 860 b) areconfigured to align with each other when halves (860 a, 860 b) arejoined, to form a continuous helical thread in housing (860). Flangerecesses (866) of halves (860 a, 860 b) are configured to align witheach other when halves (860 a, 860 b) are joined, to capture and retainthe upper flange (882) of syringe barrel (880). The distal port (884) ofsyringe barrel (880) protrudes from housing (860). Distal port (884) isconfigured to communicate fluid to and from the reservoir (886) definedby syringe barrel (880).

As shown in FIGS. 17 and 19, plunger actuation assembly (900) of thisexample comprises a pair of rotary actuator halves (910 a, 910 b), atranslating rod (920), a pair of ball hearings (930), and a plunger(940). Rotary actuator halves (910 a, 910 b) cooperate to define a knob(911) when halves (910 a, 910 b) are assembled together. Each half (910a, 910 b) has a respective bearing aperture (912), rod recess (914),spring recess (916), and a rod flange recess (918). Bearing apertures(912) are configured to enable portions of bearings (930) to protrudethrough apertures (912) without letting bearings (930) pass fullythrough apertures (912) when plunger actuation assembly (900) isassembled. When halves (910 a, 910 b) are assembled together, rodrecesses (914) cooperate to slidingly receive rod (920), enabling rod totranslate longitudinally relative to assembled halves (910 a, 910 b).Spring recesses (916) align with each other to capture the distal end ofa spring (922), which is configured to resiliently bias rod (920)upwardly relative to assembled halves (910 a, 910 b). Rod flangerecesses (918) together encompass a flange (924) of rod (920) andthereby constrain :longitudinal movement of rod (920) relative toassembled halves (910 a, 910 b) while still permitting some degree oflongitudinal movement of rod (920) relative to assembled halves (910 a,910 b). As will be described in greater detail below, such translationof rod (920) selectively unlocks engagement between bearings (930) andgrooves (864).

Each rotary actuator half (910 a, 910 b) also includes a plunger flangerecess (919). Plunger flange recesses (919) cooperate to capture aproximal flange (942) of plunger (940). Plunger (940) thus translatesunitarily with assembled halves (910 a, 910 b) relative to housing (860)and relative to syringe barrel (880). A piston (944) at the distal endof plunger (940) is positioned within syringe barrel (880). As alsonoted above, syringe barrel (880) is secured by housing (860). It shouldtherefore be understood that plunger (940) is configured to reciprocatewithin syringe barrel (880) to selectively vary the volume of reservoir(886) in syringe barrel (880), to thereby draw fluid into or expel fluidfrom reservoir (886).

As noted above, translating rod (920) of the present example comprises aspring (922) and a flange (924). While spring (922) of the presentexample comprises a coil spring, it should be understood that any othersuitable type of resilient member may be used to resiliently bias rod(920). Rod (920) of the present example further includes a pushbutton(926), a first lateral recess (928), and a second lateral recess (929).Lateral recesses (928, 929) are positioned just proximal to the distalend of rod (920), and are sized to receive portions of bearings (930)when rod (920) is translated to a distal position as shown in FIG. 20B.Rod (920) is configured such that rod (920) drives bearings (930)outwardly when rod (920) is in a proximal position as shown in FIG. 20A(in which spring (922) is omitted). When bearings (930) are in thisposition, bearings (930) protrude through apertures (912) and engagegrooves (864). When bearings (930) are engaged with grooves (864),bearings (930) prevent plunger actuation assembly (900) from translatingfreely relative to housing (860). However, the relationship betweenbearings (930) and the helical threading formed by grooves (864) willprovide translation of plunger actuation assembly (900) when plungeractuation assembly (900) is rotated relative to housing (860). When rod(920) is translated to the distal position shown in FIG. 20B, bearings(930) retract into recesses (928, 929), disengaging grooves (864). Whenbearings (930) are disengaged from grooves (864), plunger actuationassembly (900) translates freely relative to housing (860). Whilegrooves (928, 929) are longitudinally offset relative to each other inthe present example, it should be understood that grooves (928, 929) mayalternatively be located at a common longitudinal position.

In an exemplary use of inflator (850), a operator may start with plunger(940) advanced to a distal position as shown in FIG. 20A. The operatormay then position port (884) in a bowl or other container of saline todraw fluid from. In instances where port (884) is coupled with one endof flexible tube (46), the operator may position the other end offlexible tube (46) in the saline. In either case, the operator may thenadvance rod (920) distally by pushing on pushbutton (926), therebydisengaging bearings (930) from grooves (864) as shown in FIG. 20B.Next, the operator may pull plunger actuation assembly (900) proximallyrelative to housing (860), which will in turn retract plunger (940)relative to syringe barrel (880) to draw the saline (or other fluid)into reservoir (886). The operator may then remove port (884) orflexible tube (46) from the saline container and release pushbutton(926). This will enable spring (922) to drive rod (920) upwardlyrelative to halves (910 a, 910 b), which will result in rod (920)driving bearings (930) outwardly into engagement with grooves (864) asshown in FIG. 20C.

At this stage, the operator may advance plunger (940) distally in orderto purge air from reservoir (886). For instance, the operator may orientinflator (850) such that port (884) is positioned upwardly to gather airat the top of reservoir (886) before advancing plunger (940) distally inorder to purge air from reservoir (886). To purge air from reservoir(886), the operator may depress pushbutton (926) again to disengagebearings (930) from grooves (864), then push plunger actuation assembly(900) distally relative to housing (860) to advance plunger (940) withinsyringe barrel (880). Alternatively, the operator may refrain fromdepressing pushbutton (926), and may instead rotate knob (911) relativeto housing (860). Due to the engagement between bearings (930) andgrooves (864) this rotation of knob (911) relative to housing (860) willdrive plunger actuation assembly (900) distally relative to housing(860), thereby advancing plunger (940) within syringe barrel (880).

Once reservoir (886) has been sufficiently filled with fluid and air hasbeen purged, the operator may couple inflator (850) with dilationcatheter (20), such as by coupling port (884) with lateral port (26) viaa flexible tube (46). In some instances, a conventional fluid pressuregauge (not shown) may be coupled in the fluid path between port (884)and lateral port (26) (e.g., via a “T” fitting, etc.). Of course,inflator (850) may alternatively include an integral pressure gauge.With dilator (22) being suitably positioned within an anatomicalpassageway (e.g., an ostium (O), etc.), the operator may then advanceplunger actuation assembly (900) distally relative to housing (860) toadvance plunger (940) within syringe barrel (880), thereby transferringfluid from reservoir (886) to dilator (22). The operator may observe thepressure reading at the pressure gauge while advancing plunger actuationassembly (900) distally in order to determine when the appropriate fluidpressure level has been reached.

In some instances, the advancement of plunger actuation assembly (900)occurs in two stages. In the first stage, the operator may depresspushbutton (926) again to disengage bearings (930) from grooves (864),then push plunger actuation assembly (900) distally relative to housing(860) to advance plunger (940) within syringe barrel (880) through afirst range of motion that approaches but does not quite reach thedesired fluid pressure. In the second stage, the operator may releasepushbutton (926) to re-engage bearings (930) with grooves (864), thenrotate knob (911) relative to housing (860) to drive plunger actuationassembly (900) distally relative to housing (860), thereby advancingplunger (940) within syringe barrel (880) through a second range ofmotion in a more precisely controlled fashion until reaching the desiredfluid pressure.

Once the operator has attained the desired level of pressure in dilator(22) within the anatomical passageway to dilate the anatomicalpassageway, the operator may pause for an approximate, predeterminedperiod of time (e.g., approximately three seconds, etc.). The operatormay then depress pushbutton (926) to once again disengage bearings (930)from grooves (864), then pull plunger actuation assembly (900)proximally relative to housing (860). This will retract plunger (940)relative to syringe barrel (880), thereby drawing fluid from dilator(22). With dilator (22) now deflated, dilator (22) may be retracted fromthe patient. Alternatively, if the operator wishes to dilate additionalanatomical passageways, dilator (22) may be positioned in the nextanatomical passageway, and the operator may repeat the above steps todilate that next anatomical passageway. Thus, the same volume of fluidwithin reservoir (886) may be used repeatedly to dilate a plurality ofanatomical passageways, without having to withdraw dilator (22) from thepatient, and without having to decouple inflator (850) from the rest ofdilator catheter system (10), until all of the desired dilations havebeen completed. Other suitable variations of inflator (850) will beapparent to those of ordinary skill in the art in view of the teachingsherein. Similarly, other suitable ways in which inflator (850) may beused will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

I. Exemplary Alternative Inflator with Ratcheting Drive and ButtonRelease

FIGS. 21-24E depict another exemplary inflator (950). Inflator (950) ofthis example includes a housing (960), a syringe barrel (980), and aplunger actuator (1000). Housing (960) is formed by two halves (960 a,960 b) that are joined together to contain syringe barrel (980) andplunger actuator (1000). Housing (960) defines two finger grip features(962, 964) while the proximal end of plunger actuator (1000) includes apalm grip feature (1002). These grip features (962, 964, 1002) areconfigured to enable a operator to grasp and manipulate inflator (950)with a single hand by wrapping their fingers about finger grip features(962, 964) while positioning palm grip feature (1002) in the palm of thesame hand. As will be described in greater detail below, inflator (950)may be selectively actuated by the operator squeezing their hand todrive plunger actuator (1000) distally relative to housing (960); or byreleasing their grip to enable plunger actuator (1000) to retractproximally relative to housing (960).

As best seen in FIG. 22, each housing half (960 a, 960 b) defines acorresponding ratcheting block recess (972), a block latch recess (974),a pushbutton recess (976), and a flange recess (978). Ratcheting blockrecesses (972) cooperate to receive a ratcheting block (1010) andassociated spring (1018). Spring (1018) biases ratcheting block (1010)upwardly within recess (972). Block latch recesses (974) cooperate toreceive a block latch (1020) and associated spring (1024). Spring (1024)biases block latch (1020) distally within recess (974). Pushbuttonrecesses (976) cooperate to receive a pushbutton (1030) and associatedspring (1034). Spring (1034) biases pushbutton (1030) upwardly withinrecess (972). While springs (1018, 1024, 1034) all comprise coil springsin the present example, it should be understood that any other suitabletypes of resilient components or features may be used. Flange recesses(978) cooperate to receive upper flange (982) of syringe barrel (980),thereby fixedly securing syringe barrel (980) to housing (960). Othersuitable features and configurations for housing (960) will he apparentto those of ordinary skill in the art in view of the teachings herein.

FIG. 22 also shows additional features of plunger actuator (1000). Inparticular, plunger actuator (1000) of this example comprises a shaft(1004) extending distally from palm grip feature (1002), with a set ofsawteeth (1006) on the underside of shaft (1004). Shaft (1004) alsoincludes a latch engagement feature (1005) projecting from the upperside of shaft (1004). Latch engagement feature (1005) is configured tointeract with latch (1020) as will be described in greater detail below.Shaft terminates in a piston (944), which is positioned within syringebarrel (980). Plunger actuator (1000) is operable to translate relativeto housing (960), to thereby reciprocate piston (944) within syringebarrel (980). It should be understood that such reciprocation willselectively vary the volume of reservoir (986) in syringe barrel (980),to thereby draw fluid into or expel fluid from reservoir (986). As shownin FIGS. 22 and 24A-24E, a spring (988) is positioned inside reservoir(986), between the distal face of piston (1008) and the distal interiorwall of reservoir (986), to bias plunger actuator (1000) proximallyrelative to syringe barrel (980). While spring (988) comprises a coilspring in the present example, any other suitable type of resilientmember may be used. Furthermore, spring (988) may be positionedelsewhere in inflator (950).

FIG. 23 shows the proximal side of ratcheting block (1010). As shown,ratcheting block (1010) defines an aperture (1012) that is sized andconfigured to receive shaft (1004) of plunger actuator (1000). A pawlfeature (1014) is located at the bottom of aperture (1012) and is shapedto complement sawteeth (1006) of shaft (1004). A latch cam feature(1016) is located at the top of aperture (1012) and is shaped tocomplement a cam feature (1022) of block latch (1020). As will bedescribed in greater detail below, ratcheting block (1010) is operableto permit plunger actuator (1000) to freely translate from a proximalposition to a distal position; while preventing plunger actuator (1000)from retracting proximally when plunger actuator (1000) is releasedduring translation from the proximal position to the distal position. Aswill also be described in greater detail below, block latch (1020) isconfigured to keep ratcheting block (1010) disengaged from plungeractuator (1000) after pushbutton (1030) is actuated, until plungeractuator (1000) reaches a proximal home position.

FIGS. 24A-24E depict a series showing interactions between theabove-described components during operation of inflator (950). Inparticular, FIG. 24A shows plunger actuator (1000) in a proximalposition. Ratcheting block (1010) is in an upper position. andpushbutton (1030) is also in an upper position. Block latch (1020) is ina distal position. FIG. 24B shows plunger actuator (1000) advanced to adistal position. Ratcheting block (1010) remains in an upper position,pushbutton (1030) remains in an upper position, and block latch (1020)remains in a distal position. During the advancement of plunger actuator(1000) from the proximal position (FIG. 24A) to the distal position(FIG. 24B), pawl feature (1014) ratchets along sawteeth (1006) due tothe resilient bias of spring (1018). If the operator were to relax theirgrip on grip features (962, 964, 1002) during advancement of plungeractuator (1000), engagement between pawl feature (1014) and sawteeth(1006) would prevent plunger actuator (1000) from moving proximally,despite the proximally directed bias from spring (988). Plunger actuator(1000) would thus maintain its longitudinal position relative to housing(960) and also maintain its position after reaching the stage shown inFIG. 24B, until the operator depresses pushbutton (1030).

Pushbutton (1030) includes an integral, downwardly oriented projection(1032) that is operable to drive ratcheting block (1010) downwardly whenpushbutton (1030) is pushed downwardly. As shown in FIG. 24C, theresulting downward movement of ratcheting block (1010) disengages pawlfeature (1014) from sawteeth (1006). In addition, the downward movementof ratcheting block (1010) results in camming interaction between camfeatures (1016, 1022). This camming interaction drives block latch(1020) proximally until cam feature (1016) moves downwardly past camfeature (1022). As soon as cam feature (1016) passes cam feature (1022),spring (1024) drives block latch (1020) distally such that cam feature(1022) is positioned over an upper shelf (1017) of cam feature (1016).This resulting arrangement prevents ratcheting block (1010) from movingupwardly, such that block latch (1020) effectively locks ratchetingblock (1010) in the downward position where pawl feature (1014) isdisengaged from sawteeth (1006). This lock is maintained even afterpushbutton (1030) is released as shown in FIG. 24D. It should beunderstood that, at this stage, the only thing maintaining thelongitudinal position of plunger actuator (1000) relative to housing(960) is the operator's grip on grip features (962, 964, 1002).

When the operator relaxes their grip on grip features (962, 964, 1002),spring (988) drives plunger actuator (1000) proximally, as shown in thetransition from FIG. 24D to FIG. 24E. Once plunger actuator (1000)reaches the proximal position shown in FIG. 24E, latch engagementfeature (1.005) drives block latch (1020) proximally, which disengagesearn feature (1022) from upper shelf (1017) of cam feature (1016). Thisdisengagement of cam feature (1016) enables spring (1018) to driveratcheting block (1010) upwardly. In some versions, ratcheting block(1010) does not actually travel upwardly until the operator advancesplunger actuator (1000) distally just enough to enable pawl feature(1014) to seat within a valley preceding the first sawtooth (1006), asshown in FIG. 24A. The above components may be configured such thatblock latch (1020) does not travel distally (under the influence ofspring (1024)) enough to engage ratcheting block (1010) until ratchetingblock has first traveled upwardly far enough for upper shelf (1017) toclear cam feature (1022). In other words, block latch (1020) does notimpede upward movement of ratcheting block (1010) during the transitionfrom the arrangement shown in FIG. 24E back to the arrangement shown inFIG. 24A.

In an exemplary use of inflator (950), a operator may start with plungeractuator (1000) advanced to a distal position as shown in FIG. 24B. Theoperator may then position port (984) in a bowl or other container ofsaline to draw fluid from. In instances where port (984) is coupled withone end of flexible tube (46), the operator may position the other endof flexible tube (46) in the saline. In either case, the operator maythen depress pushbutton (1030) to disengage ratcheting block (1010) fromshaft (1040) as shown in FIG. 24C. While maintaining a grip on gripfeatures (962, 964, 1002), the operator may release pushbutton (1030) asshown in FIG. 241). Next, the operator may relax their grip on gripfeatures (962, 964, 1002), allowing spring (988) to drive plungeractuator (1000) proximally toward the position shown in FIG. 24E. Thiswill in turn translate piston (1008) proximally within syringe barrel(980), thereby drawing the saline (or other fluid) into reservoir (986).The operator may then remove port (984) or flexible tube (46) from thesaline container.

At this stage, the operator may advance plunger actuator (1000) distallyin order to purge air from reservoir (986). For instance, the operatormay orient inflator (950) such that port (984) is positioned upwardly togather air at the top of reservoir (986) before squeezing on gripfeatures (962, 964, 1002) to advance plunger actuator (1000) distally inorder to purge air from reservoir (986). As the operator advancesplunger actuator (1000) distally, pawl feature (1014) will ratchet alongsawteeth (1006) to prevent plunger actuator (1000) from retractingproximally if and when the operator relaxes their grip on grip features(962, 964, 1002).

Once reservoir (986) has been sufficiently filled with fluid and air hasbeen purged, the operator may couple inflator (950) with dilationcatheter (20), such as by coupling port (984) with lateral port (26) viaa flexible tube (46). In some instances, a conventional fluid pressuregauge (not shown) may be coupled in the fluid path between port (984)and lateral port (26) (e.g., via a “T” fitting, etc.). Of course,inflator (950) may alternatively include an integral pressure gauge.With dilator (22) being suitably positioned within an anatomicalpassageway (e.g., an ostium (O), etc.), the operator may then advanceplunger actuator (1000) distally relative to housing (960) to advancepiston (1008) within syringe barrel (980), thereby transferring fluidfrom reservoir (986) to dilator (22). The operator may observe thepressure reading at the pressure gauge while advancing plunger actuator(1000) distally in order to determine when the appropriate fluidpressure level has been reached. Again, pawl feature (1014) will ratchetalong sawteeth (1006) as the operator advances plunger actuator (1000)distally, to prevent plunger actuator (1000) from retracting proximallyif and when the operator relaxes their grip on grip features (962, 964,1002).

Once the operator has attained the desired level of pressure in dilator(22) within the anatomical passageway to dilate the anatomicalpassageway, the operator may pause for an approximate, predeterminedperiod of time (e.g., approximately three seconds, etc.). The operatormay then depress pushbutton (1030) to once again disengage ratchetingblock (1010) from sawteeth (1006), then relax their grip on gripfeatures (962, 964, 1002). This will allow spring (988) to drive plungeractuator (1000) proximally, thereby drawing fluid from dilator (22) backinto reservoir (986). With dilator (22) now deflated, dilator (22) maybe retracted from the patient. Alternatively, if the operator wishes todilate additional anatomical passageways, dilator (22) may be positionedin the next anatomical passageway, and the operator may repeat the abovesteps to dilate that next anatomical passageway. Thus, the same volumeof fluid within reservoir (986) may be used repeatedly to dilate aplurality of anatomical passageways, without having to withdraw dilator(22) from the patient, and without having to decouple inflator (950)from the rest of dilator catheter system (10), until all of the desireddilations have been completed. Other suitable variations of inflator(950) will he apparent to those of ordinary skill in the art in view ofthe teachings herein. Similarly, other suitable ways in which inflator(950) may be used will be apparent to those of ordinary skill in the artin view of the teachings herein.

J. Exemplary Alternative Inflator with Ratcheting Drive and ThumbringRelease

FIGS. 25-28C depict another exemplary inflator (1050). Inflator (1050)of this example includes a housing (1060), a syringe barrel (1080), anda plunger actuator assembly (1100). Housing (1060) of this example isformed as a single piece that defines a pair of upper finger gripfeatures (1062) and a pair of lower finger grip features (1064). Duringuse of inflator (1050), a operator may place their index finger betweenthe upper grip features (1062) and their other three fingers between thelower finger grip features (1064). The proximal end of plunger actuatorassembly (1100) defines a thumb ring (1102). Grip features (1062, 1064)and thumb ring (1102) are configured to enable a operator to grasp andmanipulate inflator (1050) with a single hand by engaging their fingerswith finger grip features (1062, 1064) and inserting their thumb of thesame hand through thumb ring (1102). As will be described in greaterdetail below, inflator (1050) may be selectively actuated by theoperator advancing their thumb distally to drive plunger actuatorassembly (1100) distally relative to housing (1060); or by retractingtheir thumb proximally to pull plunger actuator assembly (1100)proximally relative to housing (1060).

As best seen in FIGS. 25-28, housing (1060) of the present exampledefines a pair of notches (1068) that are configured to receivecomplementary tabs (1088) of syringe barrel (1080) to provide a securesnap-fit engagement between housing (1060) and syringe barrel (1080).Housing (1060) also defines a syringe barrel viewing recess (1066) thatpermits visualization of the amount of fluid within syringe barrel(1080) during use of inflator (1050). As best seen in FIG. 27, theinterior of housing (1060) includes a longitudinal array of annularinterior ribs (1070). Ribs (1070) each have a sawtooth profile. Othersuitable features and configurations for housing (1060) will be apparentto those of ordinary skill in the art in view of the teachings herein.

As best seen in FIGS. 28-29, plunger actuator assembly (1100) of thepresent example comprises a plunger driver (1110) and a cam driver(1130). Plunger driver includes a pair of lateral ratchet features(1112) positioned at the distal ends of respective resilient arms(1114). Resilient arms (1114) extend parallel to the longitudinal axisdefined by plunger driver (1110), yet are capable of deflecting inwardlytoward the longitudinal axis defined by plunger driver (1110) as will bedescribed in greater detail below. The distal end of plunger driver(1110) includes a piston (1116), which is positioned within syringebarrel (1080), Plunger actuator assembly (1100) is operable to translaterelative to housing (1060), to thereby reciprocate piston (1116) withinsyringe barrel (1080). It should be understood that such reciprocationwill selectively vary the volume of reservoir (1086) in syringe barrel(1080), to thereby draw fluid into or expel fluid from reservoir (1086).

Cam driver (1130) includes a rod (1132) that is integral with thumb ring(1102). Rod (1132) is slidably disposed within a bore in plunger driver(1110), such that cam driver (1130) and plunger driver (1110) arecoaxially aligned. A cam feature (1140) is secured to the distal end ofrod (1132) by a pin (1136). Cam feature (1140) is positioned within atransverse channel (1118) of plunger driver (1110) and projectslaterally from channel (1118). Cam feature (1140) includes a pair ofproximally presented cam surfaces (1142) that are positioned toselectively engage of lateral ratchet features (1112) of plunger driver(1110) as will be described in greater detail below. A spring (1138) ispositioned about rod (1132) and is configured to bias cam driver (1130)distally relative to plunger driver (1110). While spring (1138)comprises a coil spring in the present example, any other suitable typeof resilient member may be used. Furthermore, spring (1138) may bepositioned elsewhere in inflator (1050).

FIGS. 30A-30C depict a series showing interactions between theabove-described components during operation of inflator (1050). Inparticular, FIG. 30A shows plunger actuation assembly (1100) in a distalposition. Lateral ratchet features (1112) are engaged with ribs (1070)of housing (1060), preventing plunger driver (1110) from translatingproximally relative to housing (1060). When the operator pullsproximally on thumb ring (1102), this translates cam driver (1130)proximally relative to plunger driver (1100), which remainslongitudinally fixed relative to housing (1060). As shown in FIG. 30B,this retraction of cam driver (1130) drives cam feature (1140) intolateral ratchet features (1112). Cam surfaces (1142) drive lateralratchet features (1112) inwardly, causing arms (1114) to bend. Thisdisengages ratchet features (1112) from ribs (1070). With ratchetfeatures (1112) disengaged from ribs (1070), plunger driver (1110) isfree to translate proximally relative to housing (1060) as the operatorcontinues to pull proximally on thumb ring (1102). Once plunger driver(1110) reaches a proximal position as shown in FIG. 30C, the operatormay substantially release thumb ring (1102). This will enable spring(1138) to drive cam driver (1130) distally relative to plunger driver(1110). With cam driver (1130) driven distally relative to plungerdriver (1110), cam feature (1140) disengages ratchet features (1112),which deflect back outwardly under the resilient bias of arms (1114).The outwardly deflected ratchet features (1112) once again engage ribs(1070). As plunger actuator assembly (1100) is thereafter advanceddistally relative to housing (1060), ratchet features (1112) ratchetalong ribs (1070) and prevent plunger driver (1110) from translatingproximally when thumb ring (1102) is released.

In an exemplary use of inflator (1050), a operator may start withplunger actuator assembly (1100) advanced to a distal position as shownin FIG. 30A. The operator may then position port (1084) of syringebarrel (1080) in a bowl or other container of saline to draw fluid from.In instances where port (1084) is coupled with one end of flexible tube(46), the operator may position the other end of flexible tube (46) inthe saline. In either case, the operator may then pull thumb ring (1102)proximally to drive cam feature (1140) proximally, to thereby disengageratchet features (1112) from ribs (1070) as shown in FIG. 30B. Theoperator may continue to pull thumb ring (11.02) proximally to retractplunger actuation assembly (1100) proximally toward the position shownin FIG. 30C. This will in turn translate piston (1116) proximally withinsyringe barrel (1080), thereby drawing the saline (or other fluid) intoreservoir (1086). The operator may then remove port (1084) or flexibletube (46) from the saline container.

At this stage, the operator may advance plunger actuator assembly (1100)distally in order to purge air from reservoir (1086). For instance, theoperator may orient inflator (1050) such that port (1084) is positionedupwardly to gather air at the top of reservoir (1086) before pushingthumb ring (1102) distally to advance plunger actuator assembly (1100)distally in order to purge air from reservoir (1086). As the operatoradvances plunger actuator assembly (1100) distally, ratchet features(1112) will ratchet along ribs (1070) to prevent plunger actuator (1000)from retracting proximally if and when the operator releases thumbring(1102).

Once reservoir (1086) has been sufficiently filled with fluid and airhas been purged, the operator may couple inflator (1050) with dilationcatheter (20), such as by coupling port (1084) with lateral port (26)via a flexible tube (46). In some instances, a conventional fluidpressure gauge (not shown) may be coupled in the fluid path between port(1084) and lateral port (26) (e.g., via a “T” fitting, etc.). Of course,inflator (1050) may alternatively include an integral pressure gauge.With dilator (22) being suitably positioned within an anatomicalpassageway (e.g., an ostium (O), etc.), the operator may then advanceplunger actuator assembly (1100) distally relative to housing (1060) toadvance piston (1116) within syringe barrel (1080), thereby transferringfluid from reservoir (1086) to dilator (22). The operator may observethe pressure reading at the pressure gauge while advancing plungeractuator assembly (1100) distally in order to determine when theappropriate fluid pressure level has been reached. Again, ratchetfeatures (1112) will ratchet along ribs (1070) as the operator advancesplunger actuator assembly (1100) distally, to prevent plunger actuatorassembly (1100) from retracting proximally if and when the operatorreleases thumb ring (1102).

Once the operator has attained the desired level of pressure in dilator(22) within the anatomical passageway to dilate the anatomicalpassageway, the operator may pause for an approximate, predeterminedperiod of time (e.g., approximately three seconds, etc.). The operatormay then pull thumb ring (1102) proximally to drive cam feature (1140)proximally, to thereby disengage ratchet features (1112) from ribs(1070). This will allow plunger driver (1110) to translate proximallyrelative to housing (1060). The operator may continue to pull thumb ring(1102) proximally to retract plunger actuation assembly (1100)proximally toward the position shown in FIG. 30C. This will in turntranslate piston (1116) proximally within syringe barrel (1080), therebydrawing the saline (or other fluid) from dilator back into reservoir(1086). With dilator (22) now deflated, dilator (22) may be retractedfrom the patient. Alternatively, if the operator wishes to dilateadditional anatomical passageways, dilator (22) may be positioned in thenext anatomical passageway, and the operator may repeat the above stepsto dilate that next anatomical passageway. Thus, the same volume offluid within reservoir (1086) may be used repeatedly to dilate aplurality of anatomical passageways, without having to withdraw dilator(22) from the patient, and without having to decouple inflator (1050)from the rest of dilator catheter system (10), until all of the desireddilations have been completed. Other suitable variations of inflator(1050) will be apparent to those of ordinary skill in the art in view ofthe teachings herein. Similarly, other suitable ways in which inflator(1050) may be used will be apparent to those of ordinary skill in theart in view of the teachings herein.

K. Exemplary Alternative Inflator with Rotary Drive and Button Releaseof Sliding Locking Features

FIGS. 31-37C depict another exemplary inflator (1150). Inflator (1150)of this example includes a housing (1160), a syringe barrel (1180), anda plunger actuation assembly (1200). Housing (1160) is formed by twohalves (1160 a, 1160 b) that are joined together to contain syringebarrel (1180) and plunger actuation assembly (1200). As best seen inFIGS. 31-33, each half (1160 a, 1160 b) includes a window (1162) thatpermits viewing of syringe barrel (1180). In particular, a operator ofinflator (1150) may see how much fluid is in syringe barrel (1180) byviewing syringe barrel (1180) through window (1162).

As best seen in FIG. 33, each half (1160 a, 1160 b) also includes arespective helically oriented groove (1164) and flange recess (1166).Grooves (1164) of halves (1160 a, 1160 b) are configured to align witheach other when halves (1160 a, 1160 b) are joined, to form a continuoushelical thread in housing (1160). Flange recesses (1166) of halves (1160a, 1160 b) are configured to align with each other when halves (1160 a,1160 b) are joined, to capture and retain the upper flange (1182) ofsyringe barrel (1180). The distal port (1184) of syringe barrel (1180)protrudes distally from housing (1160). Distal port (1184) is configuredto communicate fluid to and from the reservoir (1186) defined by syringebarrel (1180). Each housing half (1160 a, 1160 b) also includes arespective lateral notch (1163). When halves (1160 a, 1160 b) areassembled together, notches (1163) together provide clearance for alaterally protruding portion of a pressure gauge (1185), which is anintegral feature of syringe barrel (1180) in this example. Pressuregauge (1185) may be configured and operable like any other pressuregauge (162, 262, 362, 462, 472, 482, 562, 662, 762) described herein; ormay be configured and operable in any other suitable fashion.Alternatively, pressure gauge (1185) and notches (1163) may simply beomitted if desired.

As shown in FIGS. 34-36, plunger actuation assembly (1200) of thisexample comprises a pair of rotary actuator halves (1210 a, 1210 b), alongitudinally translating rod (1220), a pair of retractable threadmembers (1230, 1231), and a plunger (1240). Rotary actuator halves (1210a, 1210 b) cooperate to define a knob (1211) when halves (1210 a, 1210b) are assembled together. Each half (1210 a, 1210 b) has a respectivepair of thread channels (1212, 1213), a rod recess (1214), a springrecess (1216), and a rod flange recess (1218). When halves (1210 a, 1210b) are assembled together, thread channels (1212, 1213) cooperate toenable thread members (1230, 1231) to selectively translate laterallyrelative to rod (1220) and thereby selectively protrude outwardly fromthe assembly of :halves (1210 a, 1210 b) as will be described in greaterdetail below. In addition, rod recesses (1214) cooperate to slidinglyreceive rod (1220), enabling rod to translate longitudinally relative toassembled halves (1210 a, 1210 b). Spring recesses (1216) align witheach other to capture the distal end of a spring (1222), which isconfigured to resiliently bias rod (1220) upwardly relative to assembledhalves (1210 a, 1210 b). Rod flange recesses (1218) together encompass aflange (1224) of rod (1220) and thereby constrain longitudinal movementof rod (1220) relative to assembled halves (1210 a, 1210 b) while stillpermitting some degree of longitudinal movement of rod (1220) relativeto assembled halves (1210 a, 1210 b). As will be described in greaterdetail below, such translation of rod (1220) selectively unlocksengagement between thread members (1230, 1231) and grooves (1164).

Each rotary actuator half (1210 a, 1210 b) also includes a plungerflange recess (1219). Plunger flange recesses (1219) cooperate tocapture a proximal flange (1242) of plunger (1240). Plunger (1240) thustranslates unitarily with assembled halves (1210 a, 1210 b) relative tohousing (1160) and relative to syringe barrel (1180). A piston (1244) atthe distal end of plunger (1240) is positioned within syringe barrel(1180). As also noted above, syringe barrel (1180) is secured by housing(1160). It should therefore be understood that plunger (1240) isconfigured to reciprocate within syringe barrel (1180) to selectivelyvary the volume of reservoir (1186) in syringe barrel (1180), to therebydraw fluid into or expel fluid from reservoir (1186), in response tolongitudinal movement of plunger actuation assembly (1200) relative tohousing (1160).

As noted above, translating rod (1220) of the present example comprisesa spring (1222) and a flange (1224). Spring (1222) bears proximallyagainst flange (1224). While spring (1222) of the present examplecomprises a coil spring, it should be understood that any other suitabletype of resilient member may be used to resiliently bias rod (1220). Rod(1220) of the present example further includes a pushbutton (1226) and apair of slots (1234, 1235) formed near the distal end of rod (1220). Asbest seen in FIG. 36, each slot (1234, 1235) is obliquely orientedrelative to the longitudinal axis of rod (1220). In addition, slot(1234) is at a vertical position that is offset from the verticalposition of slot (1235), such that slot (1235) is positioned distally inrelation to slot (1234). Thread member (1230) is secured to a pin(1232), which is slidably disposed in slot (1234). Similarly, threadmember (1231) is secured to a pin (1233), which is slidably disposed inslot (1235). Referring back to FIG. 35, thread member (1230) isconfigured to slidably fit in thread channel (1212), while thread member(1231) is configured to slidably fit in thread channel (1213). Threadchannels (1212, 1213) prevent thread members (1230, 1230 from movingalong the length of rotary actuator halves (1210 a, 1210 b); yet permitthread members (1230, 1231) to move laterally relative to rotaryactuator halves (1210 a, 1210 b).

Due to the configuration of thread channels (1212, 1213) and a caromingaction provided through cooperation between slots (1234, 1235) and pins(1232, 1233), thread members (1230, 1231) are configured to move betweenan inwardly retracted position (when rod (1220) is in a distal positionrelative to halves (1210 a, 1210 b)) and an outwardly extended position(when rod (1220) is in a proximal position relative to halves (1210 a,1210 b)). In particular, FIG. 37A shows rod (1220) in a proximalposition relative to halves (1210 a, 1210 b). As shown, thread members(1230, 1231) are in outwardly extended positions, such that the outerends of thread members (1230, 1231) protrude outwardly from halves (1210a, 1210 b) and engage grooves (1164) of housing (1160). When threadmembers (1230, 1231) are engaged with grooves (1164) of housing (1160)as shown in FIG. 37A, plunger actuation assembly (1200) will act like alead screw such that rotation of knob (1211) relative to housing (1160)will advance or retract plunger actuation assembly (1200) relative tohousing (1160), thereby advancing or retracting plunger (1240) relativeto syringe barrel (1180), depending on the direction in which knob(1211) is rotated.

It should also be understood that the configuration of thread members(1230, 1231) and grooves (1164) may provide a self-lockingfunctionality. In particular, the pressure of fluid within syringebarrel (1180) and/or the proximal bias provided by spring (1222) willnot cause plunger actuation assembly (1200) to rotate and thereby“backdrive” plunger actuation assembly (1200) proximally while threadmembers (1230, 1231) are engaged with grooves (1164). When threadmembers (1230, 1231) are engaged with grooves (1164), plunger actuationassembly (1200) will only translate relative to housing (1160) whenplunger actuation assembly (1200) is rotated relative to housing (1160)by an operator grasping knob (1211) and actively rotating knob (1211)relative to housing (1160).

When rod (1220) is translated to a distal position (e.g., by an operatorpressing pushbutton (1226) while gripping housing (1160) and/or knob(1211)) as shown in FIG. 37B, the camming action between slots (1234,1235) and pins (1232, 1233) simultaneously drives thread members (1230,1231) inwardly, such that the outer ends of thread members (1230, 1231)disengage grooves (1164) of housing (1160) and retract within halves(1210 a, 1210 b). With thread members (1230, 1231) disengaged fromgrooves (1164), plunger actuation assembly (1200) may be freely advanceddistally or retracted proximally relative to housing (1160), Due to thepresence of spring (1222), the operator must hold pushbutton (1226) in adepressed position in order to keep thread members (1230, 1231)disengaged from grooves (1164). Once the operator releases pushbutton(1226), the resilient bias of spring (1222) will drive rod (1220)proximally relative to halves (1210 a, 1210 b). Due to the cammingaction between slots (1234, 1235) and pins (1232, 1233), the proximalmovement of rod (1220) relative to halves (1210 a, 1210 b) will drivethread members (1230, 1231) simultaneously outwardly again and intoengagement with grooves (1164).

In an exemplary use of inflator (1150), a operator may start withplunger actuation assembly (1200) advanced to a distal position as shownin FIG. 37B. The operator may then position port (1184) in a bowl orother container of saline to draw fluid from, in instances where port(1184) is coupled with one end of flexible tube (46), the operator mayposition the other end of flexible tube (46) in the saline. In eithercase, the operator may then advance rod (1220) distally by pushing onpushbutton (1226), thereby disengaging thread members (1230, 1231) fromgrooves (1164) as shown in FIG. 37B. Next, the operator may pull plungeractuation assembly (1200) proximally relative to housing (1160) as shownin FIG. 37C, which will in turn retract plunger (1240) relative tosyringe barrel (1180) to draw the saline (or other fluid) into reservoir(1186). The operator may then remove port (1184) or flexible tube (46)from the saline container and release pushbutton (1226). This willenable spring (1222) to drive rod (1220) proximally relative to halves(1210 a, 1210 b), which will result in rod (1220) driving thread members(1230, 1231) outwardly and back into engagement with grooves (1164).

At this stage, the operator may advance plunger (1240) distally in orderto purge air from reservoir (1186). For instance, the operator mayorient inflator (1150) such that port (1184) is positioned upwardly togather air at the top of reservoir (1186) before advancing plunger(1240) distally in order to purge air from reservoir (1186). To purgeair from reservoir (1186), the operator may depress pushbutton (1226)again to disengage thread members (1230, 1231) from grooves (1164), thenpush plunger actuation assembly (1200) distally relative to housing(1160) to advance plunger (1240) within syringe barrel (1180).Alternatively, the operator may refrain from depressing pushbutton(1226), and may instead rotate knob (1211) relative to housing (1160).Due to the engagement between thread members (1230, 1231) and grooves(1164) this rotation of knob (1211) relative to housing (1160) willdrive plunger actuation assembly (1200) distally relative to housing(1160), thereby advancing plunger (1240) within syringe barrel (1180).

Once reservoir (1186) has been sufficiently filled with fluid and airhas been purged, the operator may couple inflator (1150) with dilationcatheter (20), such as by coupling port (1184) with lateral port (26)via a flexible tube (46). With dilator (22) being suitably positionedwithin an anatomical passageway (e.g., an ostium (O), etc.), theoperator may then advance plunger actuation assembly (1200) distallyrelative to housing (1160) to advance plunger (1240) within syringebarrel (1180), thereby transferring fluid from reservoir (1186) todilator (22). The operator may observe the pressure reading at pressuregauge (1185) while advancing plunger actuation assembly (1200) distallyin order to determine when the appropriate fluid pressure level has beenreached.

In some instances, the advancement of plunger actuation assembly (1200)occurs in two stages. In the first stage, the operator may depresspushbutton (1226) again to disengage thread members (1230, 1231) fromgrooves (1164), then push plunger actuation assembly (1200) distallyrelative to housing (1160) to advance plunger (1240) within syringebarrel (1180) through a first range of motion that approaches but doesnot quite reach the desired fluid pressure. In the second stage, theoperator may release pushbutton (1226) to re-engage thread members(1230, 1231) with grooves (1164), then rotate knob (1211) relative tohousing (1160) to drive plunger actuation assembly (1200) distallyrelative to housing (1160), thereby advancing plunger (1240) withinsyringe barrel (1180) through a second range of motion in a moreprecisely controlled fashion until reaching the desired fluid pressure.When the operator stops rotating knob (1211) relative to housing (1160),the longitudinal position of plunger actuation assembly (1200) relativeto housing (1160) will remain fixed (due to the self-locking nature ofthread members (1230, 1231), etc.) until the operator either rotatesknob (1211) again or depresses pushbutton (1226) to disengage threadmembers (1230, 1231) from grooves (1164).

Once the operator has attained the desired level of pressure in dilator(22) within the anatomical passageway to dilate the anatomicalpassageway, the operator may pause for an approximate, predeterminedperiod of time (e.g., approximately three seconds, etc.). The operatormay then depress pushbutton (1226) to once again disengage threadmembers (1230, 1231) from grooves (1164), then pull plunger actuationassembly (1200) proximally relative to housing (1160). This will retractplunger (1240) relative to syringe barrel (1180), thereby drawing fluidfrom dilator (22). With dilator (22) now deflated, the operator mayre-inflate and deflate dilator (22) several times if desired in the sameanatomical passageway, and dilator (22) may eventually be retracted fromthe patient. Alternatively, if the operator wishes to dilate additionalanatomical passageways, dilator (22) may be positioned in the nextanatomical passageway, and the operator may repeat the above steps todilate that next anatomical passageway. Thus, the same volume of fluidwithin reservoir (1186) may be used repeatedly to dilate a plurality ofanatomical passageways, without having to withdraw dilator (22) from thepatient, and without having to decouple inflator (1150) from the rest ofdilator catheter system (10), until all of the desired dilations havebeen completed. Other suitable variations of inflator (1150) will beapparent to those of ordinary skill in the art in view of the teachingsherein. Similarly, other suitable ways in which inflator (1150) may beused will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

L. Exemplary Alternative Inflator with Lateral Recess and Tubing Grip

FIGS. 38-44 depict another exemplary inflator (1250). Inflator (1250) ofthis example includes a housing (1260), a syringe barrel (1280), and aplunger actuation assembly (1300). Housing (1260) includes a window(1262) that permits viewing of syringe barrel (1280). As can be seen inFIGS. 38-40, window (1262) of this example is open along an angularextent of approximately 180°, though it should be understood that window(1262) may instead be open along any other suitable angular extent. Inaddition, as best seen in FIGS. 40 and 44, window (1262) extends to thedistal end of housing (1260), wrapping under the distal port (1284) ofsyringe barrel (1280) in the present example. Housing (1260) of thepresent example further includes a tubing retention feature (1440) atthe distal end of housing (1260). In particular, tubing retentionfeature (1440) defines a notch (1442) that is configured to receive andreleasably retain tubing (1400) that is coupled with distal port (1284)of syringe barrel (1280). By way of example only, notch (1442) maydefine a gap width that is slightly less than the outer diameter oftubing (1400) such that tubing (1400) deforms to fit in notch (1442)with a slight interference to releasably retain tubing (1400) in notch(1442).

As shown, the configuration and positioning of notch (1442) enablestubing (1400) to form a loop, with the free end (1402) of tubing beinglocated distal to inflator (1250). In some uses of inflator (1250),tubing (1400) is engaged with notch (1442) only before inflator (1250)is actually used. When actual use of inflator (1250) begins (e.g.,filling syringe barrel (1280) with saline, actuating inflator (1250) toexpand a dilator (22), etc.), tubing (1400) may be removed from notch(1442) to facilitate positioning of free end (1402) in relation to asaline source and/or in relation to a dilation catheter system (10),etc. Alternatively, tubing (1400) may remain disposed in notch (1442)when free end (1402) is positioned in a saline source to fill syringebarrel (1280). The operator may wish to selectively adjust thepositioning of tubing (1400) in notch (1442) before inserting free end(1402) in the saline source, such as by sliding tubing (1400) withinnotch (1442) or removing tubing (1400) from notch (1442) thenre-inserting tubing (1400) in notch, etc. Having tubing (1400) in notch(1442) while filling syringe barrel (1280) with saline may free up anoperator's hand. In addition or in the alternative, the retention oftubing (1400) in notch (1442) may prevent tubing (1400) from undesirablyflopping around or otherwise assuming an undesiredorientation/configuration while syringe barrel (1280) is being filled.Other suitable ways in which notch (1442) may be used will be apparentto those of ordinary skill in the art in view of the teachings herein.It should also be understood that notch (1442) is merely optional.

Aside from the different configuration of window (1262) and the presenceof tubing retention feature (1440), housing (1260) of the presentexample is substantially identical to housing (1160) described above. Inparticular, the interior of housing (1260) includes a groove similar togroove (1164); and a flange recess similar to flange recess (1166).Plunger actuation assembly (1300) of this example is substantiallyidentical to plunger actuation assembly (1200) described above, andincludes a knob (1311) and a pushbutton (1326). Unlike knob (1311)described above, knob (1311) of this example includes an angular arrayof curved recesses. Otherwise, plunger actuation assembly (1300) has allof the same features that plunger actuation assembly (1200) has,including selectively retractable thread members like thread members(1230, 1231), which selectively retract relative to housing (1260) whenpushbutton (1326) is depressed. The operation of inflator (1250) is thusidentical to the operation of inflator (1150) as described above. Itshould also be noted that syringe barrel (1280) includes an integralpressure gauge (1285) that is substantially identical to pressure gauge(1185) described above, though pressure gauge (1285) is of course merelyoptional. Other suitable features and operabilities that may beincorporated into inflator (1250) will be apparent to those of ordinaryskill in the art in view of the teachings herein.

IV. Miscellaneous

It should be understood that any of the examples described herein mayinclude various other features in addition to or in lieu of thosedescribed above. By way of example only, any of the examples describedherein may also include one or more of the various features disclosed inany of the various references that are incorporated by reference herein.

It should be understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Theabove-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Versions of the devices disclosed herein can be designed to be disposedof after a single use, or they can be designed to be used multipletimes. Versions may, in either or both cases, be reconditioned for reuseafter at least one use. Reconditioning may include any combination ofthe steps of disassembly of the device, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, versions of the device may be disassembled, and any numberof the particular pieces or parts of the device may be selectivelyreplaced or removed in any combination. Upon cleaning and/or replacementof particular parts, versions of the device may be reassembled forsubsequent use either at a reconditioning facility, or by a surgicalteam immediately prior to a surgical procedure. Those skilled in the artwill appreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, versions described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container,The sealed container may keep the instrument sterile until it is openedin a surgical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various versions of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, versions, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

1-20. (canceled)
 21. An apparatus, comprising: (a) a body, wherein thebody includes a first locking feature; (b) a reservoir having a fluidcapacity; and (c) a plunger assembly, wherein the plunger assembly ismovable relative to the body to selectively vary the fluid capacity ofthe reservoir, wherein the plunger assembly comprises: (i) a housing,(ii) an actuating body configured to actuate relative to the housingbetween a first position and a second position, wherein the actuatingbody is resiliently biased toward either the first position or thesecond position, and (iii) a second locking feature configured to engagethe first locking feature to selectively maintain a location of theplunger assembly at a plurality of selected longitudinal positions inrelation to the body, wherein the second locking member is configured todisengage the first locking feature at the plurality of selectedlongitudinal positions in relation to the body in order to selectivelyallow linear translation of the plunger assembly relative to the body toselectively vary the fluid capacity of the reservoir, wherein theactuating body is configured to drive the second locking feature toengage the first locking feature while in the first position, whereinthe actuating body is configured to drive the second locking feature todisengage the first locking feature while in the second position. 22.The apparatus of claim 21, wherein the first and second locking featuresare configured to selectively engage each other by one of the first orsecond locking features moving linearly along a path that is transverseto a longitudinal axis defined by the plunger assembly.
 23. Theapparatus of claim 21, wherein the plunger assembly further comprises aspring configured to resiliently bias the actuating body toward eitherthe first position or the second position.
 24. The apparatus of claim21, wherein the plunger assembly is rotatable relative to the body toselectively vary the fluid capacity when the second locking feature isengaged with the first locking feature.
 25. The apparatus of claim 21,wherein the distal end of the actuating body defines a cam slot.
 26. Theapparatus of claim 25, wherein the second locking feature comprises aretractable threaded member coupled with the actuating body via the camslot.
 27. The apparatus of claim 21, wherein the apparatus furhtercomprises a pressure gauge.
 28. The apparatus of claim 27, wherein thepressure gauge is fixed to the body.
 29. The apparatus of claim 21,further comprising a tubing in fluid communication with the reservoir.30. The apparatus of claim 29, where the body define a notch, whereinthe notch is dimensioned to selectively couple with the tubing.
 31. Theapparatus of claim 21, wherein the housing further comprises a knob,wherein the actuating body further comprises a push button housed withinthe knob.
 32. The apparatus of claim 31, wherein the knob defines aplurality of recesses.
 33. The apparatus of claim 21, wherein the bodydefines a window.
 34. The apparatus of claim 21, wherein the firstlocking feature comprises a threading.
 35. An apparatus, comprising: (a)a body, wherein the body includes a first locking feature; (b) a plungerassembly, wherein the body and the plunger assembly define a fluidcapacity, wherein the plunger assembly is movable relative to the bodyto vary the fluid capacity, wherein the plunger assembly comprises: (i)a housing defining a longitudinal axis and a channel oriented transverseto the longitudinal axis, (ii) a reciprocating member slidably disposedwithin the housing, and (iii) a thread member slidably disposed withinthe channel, wherein the reciprocating member is configured to actuatethe thread member, wherein the thread member is configured to engage thefirst locking feature to selectively maintain a location of the plungerassembly at a plurality of selected longitudinal positions in relationto the body, wherein the thread member is configured to disengage thefirst locking feature at the plurality of selected longitudinalpositions in relation to the body in order to selectively allow lineartranslation of the plunger assembly relative to the body to selectivelyvary the fluid capacity of the reservoir.
 36. The apparatus of claim 35,wherein the first locking feature comprises a helical thread.
 37. Theapparatus of claim 35, wherein the plunger assembly further comprises asyringe barrel.
 38. The apparatus of claim 37, wherein the body definesa window, wherein a portion of the syringe barrel is viewable within thewindow.
 39. The apparatus of claim 25, wherein the housing is slidablewithin the body.
 40. An apparatus, comprising: (a) a body, wherein thebody includes a first locking feature; (b) a reservoir having a fluidcapacity; and (c) a plunger assembly, wherein the plunger assembly ismovable relative to the body to selectively vary the fluid capacity ofthe reservoir, wherein the plunger assembly comprises: (i) a housing,(ii) an actuating body configured to actuate relative to the housingbetween a first position and a second position, wherein the actuatingbody is resiliently biased toward either the first position or thesecond position, and (iii) a second locking feature configured to engagethe first locking feature to selectively maintain a location of theplunger assembly at a plurality of selected longitudinal positions inrelation to the body, wherein the actuating body is configured to drivethe second locking feature to engage the first locking feature while inthe first position, wherein the actuating bod is configured to drive thesecond locking feature to disengage the first locking feature while inthe second position.